Recall Weekly
Serious riskFDA DeviceClass I

Arrow PICC kits recalled for possible drug sterility problem

Arrow International included lidocaine, bupivacaine, and saline solution from a supplier with quality issues in multiple PICC and JACC catheter kits. The anesthetic and saline components may be ineffective or contaminated, which could cause serious infection or other life-threatening complications if used.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if your facility received any of the affected catheter kit models listed in this recall.
  2. Do not use kits matching the recalled lot numbers; contact Arrow International or your distributor for a replacement.
  3. Report any adverse events or product issues to the FDA MedWatch program.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR x 55CM w Biopatch/DLX-45541-HPKB; PICC/DELTA KIT: 2L 5.5 FR X 50 CM/ASK-45052-MC; AGBA PI PICC KIT: 1L 4.5FR 40CM/CDC-44041-HPK1A; AGBA PI PICC KIT 2-LUMEN: 5.5 FR X 40CM/CDC-44052-HPK1A; AGBA PICC/DELTA FG: 2-L 5.5 FR X 40 CM/CDC-44052-VPS2; PI AGBA PICC KIT: 3-L 6 FR X 50 CM/CDC-45063-HPK1A; AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM/CDC-45541-VPS2; AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM/CDC-45552-VPS2; PICC/VPS 1L 4.5 FR/ASK-45541-CHS; PI AGBA PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UOI2; PICC KIT: 2L 5.5FR 55CM AGBA VPS/ASK-45552-CHS; PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-UOI2; PICC KIT: 3L 6FR 55CM AGBA/ASK-45563-CHS; PI JACC KIT: 3L 6 FR X 25 CM CG+/ASK-42563-LTAC; PI JACC KIT: 1-L 4.5 FR X 25 CM CG+/CDC-42541-JX1A; PI JACC KIT: 2-L 5.5 FR X 25 CM CG+/CDC-42552-JX1A; PI JACC KIT: 3-L 6 FR X 25 CM CG+/CDC-42563-JX1A; PI JACC KIT: 2-L 5.5 FR X 30 CM CG+/CDC-43052-JX1A; PI JACC KIT: 3-LUMEN: 6 FR X 30 CM CG+/CDC-43063-JX1A; PICC KIT: 2-L 4 FR X 55 CM/CDC-05542-PK1A
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 35 products — see all of them.

Details

Units affected
3,481
Illnesses reported
None reported
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Classification
Class I
Recall number
Z-2378-2026

In the FDA's words

Description
Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR x 55CM w Biopatch/DLX-45541-HPKB; PICC/DELTA KIT: 2L 5.5 FR X 50 CM/ASK-45052-MC; AGBA PI PICC KIT: 1L 4.5FR 40CM/CDC-44041-HPK1A; AGBA PI PICC KIT 2-LUMEN: 5.5 FR X 40CM/CDC-44052-HPK1A; AGBA PICC/DELTA FG: 2-L 5.5 FR X 40 CM/CDC-44052-VPS2; PI AGBA PICC KIT: 3-L 6 FR X 50 CM/CDC-45063-HPK1A; AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM/CDC-45541-VPS2; AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM/CDC-45552-VPS2; PICC/VPS 1L 4.5 FR/ASK-45541-CHS; PI AGBA PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UOI2; PICC KIT: 2L 5.5FR 55CM AGBA VPS/ASK-45552-CHS; PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-UOI2; PICC KIT: 3L 6FR 55CM AGBA/ASK-45563-CHS; PI JACC KIT: 3L 6 FR X 25 CM CG+/ASK-42563-LTAC; PI JACC KIT: 1-L 4.5 FR X 25 CM CG+/CDC-42541-JX1A; PI JACC KIT: 2-L 5.5 FR X 25 CM CG+/CDC-42552-JX1A; PI JACC KIT: 3-L 6 FR X 25 CM CG+/CDC-42563-JX1A; PI JACC KIT: 2-L 5.5 FR X 30 CM CG+/CDC-43052-JX1A; PI JACC KIT: 3-LUMEN: 6 FR X 30 CM CG+/CDC-43063-JX1A; PICC KIT: 2-L 4 FR X 55 CM/CDC-05542-PK1A Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. REF(Material)/UDI-DI/Lot(Batch): DLX-35563-HPKC/10801902193275/33F25D0520; ASK-44552-ABKB/10801902140798, 10801902216677/33X25K0002, 33S24A0529; ASK-45552-MHBV/10801902193275/33F25K0372, 33F25M0199, 33F26A1534, 33F24L0348; DLX-45541-HPKB/10801902193275, 10801902208849/33F25G0393, 33F25L0055, 33F26A1570, 33F24D0604; ASK-45052-MC/10801902216660/33S24A1242; CDC-44041-HPK1A/10801902193275/33F24K0430; CDC-44052-HPK1A/10801902193275/33F25D0241; CDC-44052-VPS2/10801902193275/33F25E0514; CDC-45063-HPK1A/10801902193275/33F25D0242; CDC-45541-VPS2/50801902120781, 10801902193275/33S24A0211, 33F25C0699; CDC-45552-VPS2/10801902193275/33F25E0704; ASK-45541-CHS/10801902193275/33F26A1422, 33F24L0897; ASK-45541-UOI2/10801902193275/33F24L0991; ASK-45552-CHS/10801902193275/33F26A1395, 33F25G0260; ASK-45552-UOI2/10801902193275/33F24L0431; ASK-45563-CHS/10801902193275/33F25A0199; ASK-42563-LTAC/10801902203271/33F24F0852; CDC-42541-JX1A/10801902193275/33F26A1469, 33F24J0135; CDC-42552-JX1A/10801902193275/33F25D0561, 33F24L0285; CDC-42563-JX1A/10801902193275, 10801902170863/33F25C0702, 33F25D0562, 33F25G0311, 33F25J0437, 33F24D0507; CDC-43052-JX1A/10801902193275/33F25M0062, 33F24J0120; CDC-43063-JX1A/10801902193275, 10801902188332/33F25G0003, 33F26B0805, 33F25D0240; CDC-05542-PK1A/10801902193275, 50801902116715/33F25H0436, 33F25H0576, 33F24D0325 Distribution: US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR. Affected quantity: 3,481
Hazard
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

35 products in this recall

Arrow kits with lidocaine and bupivacaine recalled for sterility risk

Arrow is recalling 35 kits and sets that contain lidocaine, bupivacaine, or 0.9% sodium chloride from a supplier that was itself recalled for quality issues. If the sterility of these water-based injectable drugs is compromised, it could lead to serious or life-threatening injuries. No injuries have been reported, and the products were distributed nationwide.

The agency lists each product separately. Check every one you might have.

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