Medline Medical Convenience Kits Recalled for Syringe Defects
Medline Convenience kits containing plastic syringes are being recalled due to leaks, breakage, and quality issues that may pose a risk to patient health. Multiple kit types have been distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of medical devices with potential risk of patient harm from syringe leaks, breakage, and quality defects. No illnesses or injuries have been reported, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported, yielding a High severity score.
Plain-English summary
Medline Industries, LP is recalling multiple Convenience kits due to defective plastic syringes. The syringes are subject to an FDA Safety Alert issued on March 19, 2024. The kits have leaks, breakage, and other quality issues that may pose a risk to patient health.
The recall affects multiple kit types, including ADMIT KIT, BRANSON SUPPLEMENTAL PACK, L & D PACK-LF, FAMILY PLANNING PACK, NEW LIFE PACK, RADIOLOGY PACK, AMBULATORY MINI PACK, and NURSING SKILLS. These kits have been distributed worldwide. Numerous lot numbers across the product line are included in this recall.
Healthcare facilities and individuals with these kits should refer to the FDA recall notice for information about affected lot numbers and appropriate next steps.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Number DYNDA3019; 3) L & D PACK-LF , Pack Number DYNJ16121O ; 4) FAMILY PLANNING PACK, Pack Number DYNJ59783C ; 5) NEW LIFE PACK , Pack Number DYNJ69208A ;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- syringe-leakage
- syringe-breakage
- device-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- DYKA1225B
- Lot Number 21GMC515
- DYNDA3019
- Lot Number 23BBO847
- Lot Number 23GBI102
- Lot Number 23HBO766
- DYNJ16121O
- Lot Number 23BBR366
- Lot Number 23DBR520
- Lot Number 23FBU745
- Lot Number 23GBV975
- Lot Number 23IBR246
- Lot Number 23LBR806
- Lot Number 24ABR196
- DYNJ59783C
- Lot Number 21KMF298
- Lot Number 23FMC164
- DYNJ69208A
- Lot Number 22KBV360
- Lot Number 23FBE076
Distribution
Distribution scope not specified by the agency.
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