Medline surgical convenience kits recalled due to defective plastic syringes
Medline Industries is recalling multiple surgical convenience kits containing defective plastic syringes. The syringes may leak or break, posing a risk to patient health during medical procedures.
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 recall of medical devices used in high-risk surgical procedures. The identified defects (leaks, breakage) in syringes represent a risk-of-harm in the context of sterile surgical procedures where contamination could cause serious patient harm. No illnesses or injuries have been reported to date.
Plain-English summary
Medline Industries, LP is recalling multiple surgical and medical convenience kits containing plastic syringes affected by an FDA safety alert. The syringes have been found to have leaks, breakage, and other quality defects that may pose a risk to patient health.
The affected kits include various surgical trays and packs used in procedures including arthroscopy, craniotomy, spinal fusion, and other surgical interventions. The products were distributed worldwide and are identified by specific pack numbers and lot numbers available in the FDA recall notice.
Healthcare providers and facilities that have received these kits should stop using the affected products and contact Medline Industries for instructions regarding return or replacement.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY, Pack Number AM110A ; 3) HIP , Pack Number BM200A ; 4) SHOULDER ARTHROSCOPY, Pack Number BM230A ; 5) KNEE ARTHROSCOPY, Pack Number BM240A ; 6) PODIATRY PACK
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leakage
- breakage
- contamination-risk
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)
- 00-399024X
- Lot Number 19CBL066
- Lot Number 19FBI397
- Lot Number 19RBC685
- Lot Number 19HBD864
- Lot Number 19JBV149
- Lot Number 20ABH766
- Lot Number 20ABO115
- Lot Number 20CBC862
- AM110A
- Lot Number 21GBK629
- Lot Number 19HBC424
- Lot Number 19JBR312
- Lot Number 19KBL415
- Lot Number 20ABK847
- Lot Number 20GBU689
- Lot Number 20HBK170
- Lot Number 20LBN052
- Lot Number 20LBW697
- Lot Number 21CBB960
Distribution
Distribution scope not specified by the agency.
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