Medline procedural kits recalled for syringe leaks and breakage
Medline procedural kits contain plastic syringes with leaks and breakage that may pose health risks. The affected kits are used for delivery procedures and 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 recall involves a medical device (FDA Class II) with identified quality defects in syringes used during delivery procedures. Although no illnesses or injuries have been reported, the affected product constitutes a risk-of-harm product where injury has not yet been reported, per the severity rubric criterion for Score 3.
Plain-English summary
Medline Industries is recalling four models of procedural kits used in delivery procedures: the Infant Delivery Kit (pack number DYKM1426), SR OB Delivery kits (pack numbers DYNJ908583 and DYNJ908583A), and VAG Delivery kit (pack number DYNJ909097). These kits contain plastic syringes that are subject to an FDA Safety Alert issued on March 19, 2024.
The syringes in these kits have been identified with quality issues including leaks, breakage, and other defects. These issues may pose a risk to patient health during delivery procedures.
The affected kits are distributed worldwide and are used by healthcare facilities and medical professionals. Multiple specific lot numbers are affected. Healthcare providers should stop using kits with affected lot numbers and contact the manufacturer for guidance on replacement options.
The recalled product
- Product
- Medline procedural kits labeled as: 1) INFANT DELIVERY KIT , Pack Number DYKM1426; 2) SR OB DELIVERY , Pack Number DYNJ908583; 3) SR OB DELIVERY , Pack Number DYNJ908583A; 4) VAG DELIVERY, Pack Number DYNJ909097
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leakage
- breakage
- device-malfunction
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)
- DYKM1426
- Lot Numbers: 21HME852
- Lot Numbers: 21JMB937
- Lot Numbers: 22AMC931
- Lot Numbers: 22BMH636
- Lot Numbers: 22GMC855
- Lot Numbers: 22HMD453
- Lot Numbers: 22JMA597
- Lot Numbers: 22LMF030
- Lot Numbers: 23JMB439
- Lot Numbers: 24AMF833
- DYNJ908583
- Lot Numbers: 23BBI474
- Lot Numbers: 23GBU194
- Lot Numbers: 23HBI662
- DYNJ908583A
- Lot Numbers: 23HBU557
- Lot Numbers: 23JBD374
- Lot Numbers: 23KBO704
- Lot Numbers: 23KBW138
Distribution
Distribution scope not specified by the agency.
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