Medline Convenience Kits recalled for potential sterility breach in ChloraPrep applicators
Several Medline Convenience Kits contain BD ChloraPrep Clear and FREPP Clear applicators with wrinkled paper packaging that may compromise the sterile barrier. If the packaging is breached, the applicators could be exposed to microbial contamination, which could lead to localized or serious infection in patients.
From the FDA notice · Read the official notice ↗ · All Medline recalls
What to do
- Check if you have one of the affected kits by matching your catalog number and lot number to the FDA recall list
- Stop using affected kits and quarantine them
- Contact Medline or your healthcare provider for instructions on replacement or safe disposal
- Monitor patients who may have used these kits for signs of infection
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y, Catalog Number: CDS840396Y; 3) CDS983348AA, Catalog Number: CDS983348AA; 4) CDS983348AB, Catalog Number: CDS983348AB; 5) CDS983672O, Catalog Number: CDS983672O; 6) CDS983672P, Catalog Number: CDS983672P; 7) DYKM1982, Catalog Number: DYKM1982; 8) DYNDA1080, Catalog Number: DYNDA1080; 9) DYNJ67490C, Catalog Number: DYNJ67490C; 10) DYNJ907400D, Catalog Number: DYNJ907400D; 11) DYNJ908990A, Catalog Number: DYNJ908990A
- Sold in
- Nationwide
- Made for
- Adults
This recall covers 16 products — see all of them.
Details
- Units affected
- 4636 kits
- Illnesses reported
- None reported
- Manufactured in
- 3 Lakes Dr, N/A, Northfield, IL, United States
- Classification
- Class II
- Recall number
- Z-3049-2026
In the FDA's words
- Description
- Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y, Catalog Number: CDS840396Y; 3) CDS983348AA, Catalog Number: CDS983348AA; 4) CDS983348AB, Catalog Number: CDS983348AB; 5) CDS983672O, Catalog Number: CDS983672O; 6) CDS983672P, Catalog Number: CDS983672P; 7) DYKM1982, Catalog Number: DYKM1982; 8) DYNDA1080, Catalog Number: DYNDA1080; 9) DYNJ67490C, Catalog Number: DYNJ67490C; 10) DYNJ907400D, Catalog Number: DYNJ907400D; 11) DYNJ908990A, Catalog Number: DYNJ908990A The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening. 1) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABC933; 2) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABK089; 3) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABL893; 4) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBG163; 5) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24KBK977; 6) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24BBO585; 7) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24CBR417; 8) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24FBS930; 9) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24IBK539; 10) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24ABM288; 11) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24ABR888; 12) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24EBB218; 13) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24EBM057; 14) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24FBH873; 15) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24HBG929; 16) CDS983348AB, UDI-DI: 10198459136986(each), 40198459136987(case), Lot Number: 25ABK077; 17) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24BBC413; 18) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24CBQ574; 19) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24IBC602; 20) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24JBC919; 21) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24JBK787; 22) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24JBL738; 23) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24KBB600; 24) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24KBE775; 25) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 23JBR840; 26) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 23KBM370; 27) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 23LBD735; 28) CDS983672P, UDI-DI: 10198459149139(each), 40198459149130(case), Lot Number: 25ABI289; 29) CDS983672P, UDI-DI: 10198459149139(each), 40198459149130(case), Lot Number: 24LBO787; 30) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 25BBB356; 31) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 23LBU657; 32) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 24CBF023; 33) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 24CBL355; 34) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 24KBA176; 35) DYNDA1080, UDI-DI: 10884389388679(each), 40884389388670(case), Lot Number: 25BBB185; 36) DYNDA1080, UDI-DI: 10884389388679(each), 40884389388670(case), Lot Number: 24EBE506; 37) DYNDA1080, UDI-DI: 10884389388679(each), 40884389388670(case), Lot Number: 24GBK362; 38) DYNJ67490C, UDI-DI: 10195327631710(each), 40195327631711(case), Lot Number: 24BBN881; 39) DYNJ907400D, UDI-DI: 10195327538552(each), 40195327538553(case), Lot Number: 24BBL947; 40) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 25ALA775; 41) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 25CLA341; 42) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 24ILA196; 43) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327
- Hazard
- The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.
16 products in this recall
Medline convenience kits recalled for possible sterility breach
Medline is recalling 16 convenience kit products that contain BD ChloraPrep Clear or FREPP Clear antiseptic applicators. Wrinkles in the paper lidding may extend to the seal, which could break the sterile packaging and allow microbial contamination. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, Model Number: DYKMBNDL199AZ-3048-2026 · 104 kits
- Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y, Catalog Number: CDS840396Y; 3) CDS983348AA, Catalog Number: CDS98334… (this page)Z-3049-2026 · 4636 kits
- Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog Number: DYKM1414; 3) DYNDH1462A, Catalog Number: DYNDH1462A; 4)…Z-3050-2026 · 58037 kits
- Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920; 2) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920AZ-3051-2026 · 17,750 kits
- Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437DZ-3052-2026 · 176 kits
- Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375CZ-3053-2026 · 300 kits
- Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Number: DYNDH1983A; 3) PEDI EMERGENCY…Z-3054-2026 · 434,595 kits
- Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295Z-3055-2026 · 1840 kits
- Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV START KIT, Model Number: DYKM1000B; 3) KIT, I V START NSK, Model…Z-3056-2026 · 22736 Kits
- Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2) BLOOD CULTURE KIT 2 W/CONNECT, Model Number: DYNDH1487AZ-3057-2026 · 3650 kits
- Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT, Catalog Number: DYKS1128C; 3) PRE OP KIT, Catalog Number: DYKS1216I;…Z-3058-2026 · 13032 kits
- Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG DELIVERY ADMISSION BAG, Model Number: DYKA1054FZ-3059-2026 · 3752 kits
- Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702BZ-3060-2026 · 352 kits
- Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number: DYKM2751A; 3) CATARACT PREOP KIT, Model Number: DYKS1583A; 4)…Z-3061-2026 · 2080 kits
- Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; 2) SHOULD BLOCK KIT, Model Number: DYKM1881A; 3) TRIMA KIT, Model Number: DY…Z-3062-2026 · 18290 kits
- Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2) WHOLE BLOOD PHLEBOTOMY KIT, Catalog Number: DYNDB3005D; 3) QP KIT, Catalog Nu…Z-3063-2026 · 996692 kits
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