Medline surgical procedure kits recalled due to defective plastic syringes
Medline is recalling surgical procedure kits containing plastic syringes that may leak or break. The kits were distributed worldwide and may pose a risk to patient health.
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 without reported hospitalizations or injuries. However, the recalled kits are used in surgical procedures where syringe leaks or breakage could pose a risk to patient health. The quality defects have been identified in the products, meeting the criteria for High severity as risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling medical procedural kits that contain plastic syringes. The affected kits include multiple types such as arthrogram trays, circumcision trays, breast biopsy kits, catheter insertion trays, and others.
The plastic syringes in these kits are affected by quality issues including leaks and breakage. These defects may pose a risk to patient health.
The affected kits were distributed worldwide. The recall is related to an FDA Safety Alert issued on March 19, 2024, regarding plastic syringes.
The recalled product
- Product
- Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS12670A; 3) CIRCUMCISION TRAY, Pack Number CIT6860A; 4) CIRCUMCISION TRAY, Pack Number CIT6715; 5) CIRCUMCISION TRAY, Pack Number DYNDA2271; 6) CIRCUMCIS
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- syringe-leak
- syringe-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)
- MNS11965A
- Lot Number 2023120190
- MNS12670A
- Lot Number 2022030490
- CIT6860A
- Lot Number 2022111480
- CIT6715
- Lot Number 2022080190
- DYNDA2271
- Lot Number 2022082290
- CIT7020
- Lot Number 2023051290
- CIT7210
- Lot Number 2023073190
- CIT6720A
- Lot Number 2023092690
- CIT6665
- Lot Number 2024021990
- Lot Number 21CBA170
- CIT6050
Distribution
Distribution scope not specified by the agency.
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