Medline medical convenience kits with syringes recalled due to leakage and breakage
Medline is recalling multiple medical convenience kits containing plastic syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The recall affects kits 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: FDA Class II medical device recall with identified quality hazards (leaks and breakage) in syringes used in medical procedures. No illnesses or injuries have been reported, but the defects pose a potential risk to patient health, fitting the criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling multiple medical convenience kits that contain plastic syringes. The kits affected include several types identified by pack numbers: PSP - VAMC Long Beach (Pack 146255), Insertion Tray (CVI5080), Incision & Drainage Tray (DYNDA1063), Drainage Access Pack (DYNJ44599I), Procedure Drainage Kit (DYNJ66416), Drainage Tray (DYNJ68767), and Incision and Drainage Tray (P737057).
The plastic syringes in these kits have been identified with leaks, breakage, and other quality issues. These issues may pose a risk to patient health. The defects are related to an FDA Safety Alert issued on March 19, 2024.
The affected kits have been distributed worldwide. Multiple lot numbers have been identified for each kit type and are listed in the FDA recall notice. Individuals and healthcare facilities should check whether they have received any of the affected lots.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255; 2) INSERTION TRAY, Pack Number CVI5080; 3) INCISION & DRAINAGE TRAY, Pack Number DYNDA1063; 4) DRAINAGE ACCESS PACK 319701 , Pack Number DYNJ44599I ; 5) PROCEDURE DRAINAGE KIT, Pack Numb
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leakage
- breakage
- quality-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)
- 146255
- Lot Number 23KBP730
- Lot Number 23JBV770
- Lot Number 23BBJ516
- Lot Number 23ABS205
- Lot Number 22LBQ260
- Lot Number 22LBF150
- CVI5080
- Lot Number 24ABR654
- Lot Number 24ABS414
- DYNDA1063
- Lot Number 21JBR507
- DYNJ44599I
- Lot Number 21FBO112
- Lot Number 21GBQ754
- Lot Number 21HBU200
- Lot Number 21KBM267
- Lot Number 21LBQ208
- Lot Number 22NBE952
- Lot Number 22EBA808
Distribution
Distribution scope not specified by the agency.
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