MEDLINE INDUSTRIES, LP - Northfield
707 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for MEDLINE INDUSTRIES, LP - Northfield and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-07-26FDA-DeviceClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE PACK, Model Number 00-400305R; b) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936C; c) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936D; d) ANGIOGRAM, Model Number DYNJ0149444N; e) DIALYSIS CATH INSERTION PK-LF, Model Number DYNJ0198765G; f) PICC LINE PACK-LF, Model Number DYNJ0275614F; g) ANGIOGRAPHY PACK-LF, Model Number DYNJ0290716M; h) ANGIO CATH LAB PACK-LF, Model Number DYNJ03
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-401318M; b) ANGIOGRAPHY OR, Model Number CDS984944C; c) ANGIOGRAM, Model Number DYNJ0149444M; d) EP LAB DEVICE PACK-LF, Model Number DYNJ0160556D; e) VASCULAR ANGIO PACK-LF, Model Number DYNJ0201109AG; f) ANGIO PACK-LF, Model Number DYNJ0373279M; g) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121I; h) IPMC ANGIOGRAPHY PACK-LF, Model Number DYN
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220; b) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773; c) PERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B; d) PERI NEURO BLOCK PACK-LF, Model Number DYNJ0703127A; e) PERI NEURO BLOCK PACK-LF, Model Number DYNJ42367B; f) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1571; g) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJRA0656A; h) CVOR ANGIOGRA
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number DYNJ45158A
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ81722; b) PAIN BLOCK TRAY, Model Number DYNJRA0827A; c) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA0881; d) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA0881A; e) PAIN TRAY, Model Number DYNJRA1603; f) FEMORAL BLOCK TRAY, Model Number DYNJRA1739A; g) TAP BLOCK, Model Number DYNJRA1823; h) NERVE BLOCK PREP TRAY, Model Number DYNJRA1837; i) PAIN PREP TRAY
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE, Model Number DYNJ61476
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceClass IIMedline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use during diagnostic ultrasound procedures
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-19FDA-DeviceClass IIMEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K; e) BSHR TOTAL HIP-LF, Model Number DYNJ24526P; f) TOTAL KNEE ARTHROPLASTY PACK, Model Number DYNJ26425L; g) TOTAL KNEE PACK 319735, Model Number DYNJ44635I; h) HIP ARTHROPLASTY PACK, Model Number DYNJ50072F; i) LEXINGTON TOTAL JOINT PACK, Model Number DYNJ55655
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
- 2023-07-19FDA-DeviceClass IIMEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PACK, Model Number VAL050EEPKB
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
- 2023-07-19FDA-DeviceClass IIMEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
- 2023-07-19FDA-DeviceClass IIMEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
- 2023-07-19FDA-DeviceClass IIMEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
- 2023-07-19FDA-DeviceClass IIMEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
- 2023-07-19FDA-DeviceClass IIMEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
- 2023-06-28FDA-DeviceClass IIMEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not augmenting the dose after failure per ISO 11137.
- 2023-06-07FDA-DeviceClass IIProcedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B.
The kits were damaged by water.
- 2023-04-26FDA-DeviceClass IICenturion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
The CirClamp subassembly found in the kit was the incorrect size.
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