Medline Fetal Surgery Kits Recalled Due to Defective Plastic Syringes
Medline Industries is recalling procedural kits containing plastic syringes that may leak or break. The syringes were identified in a March 2024 FDA Safety Alert 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 of medical devices used in surgical procedures. While the identified defects (leaks, breakage) pose a potential risk to patient health, no illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling two procedural kits containing plastic syringes. The recalled kits are labeled Fetal Surgery-LF (Pack Number CDS840214Q, Lot Number 23IBC884) and Fetal Surgery CDS-LF (Pack Number CMPJ26754O, Lot Number 23HBE567).
These syringes are affected by quality defects identified in an FDA Safety Alert issued on March 19, 2024. The identified defects include leaks, breakage, and other quality issues that may pose a risk to patient health. The affected kits have been distributed worldwide.
The recalled product
- Product
- Medline procedural kits labeled as: 1) FETAL SURGERY-LF, Pack Number CDS840214Q; 2) FETAL SURGERY CDS-LF, Pack Number CMPJ26754O
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
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 (4)
- CMPJ26754O
- Lot Number 23HBE567
- CDS840214Q
- Lot Number 23IBC884
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 27 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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