Medline medical convenience kits recalled due to syringe quality defects
Medline is recalling multiple medical convenience kits worldwide that contain plastic syringes with defects that may leak or break, posing a risk to patient safety.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a Class II FDA recall of medical devices (plastic syringes) identified as risk-of-harm products due to potential leakage and breakage. No illnesses or injuries have been reported in the source, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling multiple medical convenience kits distributed worldwide that contain plastic syringes affected by quality issues. The recalled products include the Sterile Lidocaine Syringe Pack, Pediatric EP Pack, Cardiac Minor-LF Pack, Cardiac Minor Surgicount Pack, and Pediatric EP Pack MHS, each with specific affected lot numbers identified.
The plastic syringes in these kits may leak, break, or experience other quality issues that could pose a risk to patient health. This recall is related to an FDA Safety Alert issued on March 19, 2024.
Healthcare facilities and practitioners who have received these kits should stop using the affected lot numbers and contact Medline Industries for guidance on return, replacement, or other appropriate actions.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A ; 2) PEDIATRIC EP PACK , Pack Number DYNJ45158A ; 3) CARDIAC MINOR-LF, Pack Number DYNJ51939; 4) CARDIAC MINOR SURGICOUNT PACK , Pack Number DYNJ56573; 5) PEDIATRIC EP…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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)
- DYNDM1076A . Lot Number 19CBP748
- DYNDM1076A . Lot Number 19DBH317
- DYNDM1076A . Lot Number 19FBT944
- DYNJ45158A . Lot Number 21KBK059
- DYNJ45158A . Lot Number 21LBB289
- DYNJ45158A . Lot Number 19ABZ159
- DYNJ45158A . Lot Number 22DBS953
- DYNJ45158A . Lot Number 22GBC899
- DYNJ45158A . Lot Number 22GBE801
- DYNJ45158A . Lot Number 19FBG969
- DYNJ45158A . Lot Number 19FBM779
- DYNJ45158A . Lot Number 19GBS210
- DYNJ45158A . Lot Number 19HBS882
- DYNJ45158A . Lot Number 19IBN282
- DYNJ45158A . Lot Number 19JBB002
- DYNJ45158A . Lot Number 23ABR333
- DYNJ45158A . Lot Number 23CBK931
- DYNJ45158A . Lot Number 23HBJ279
- DYNJ45158A . Lot Number 23IBF733
- DYNJ45158A . Lot Number 20HBR669
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 81 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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