Medline Procedural Kits Recalled Due to Defective Plastic Syringes
Medline is recalling multiple procedural kits containing plastic syringes that may leak, break, or have quality defects. These defects may pose a risk to patient health during surgical 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: This is an FDA Class II recall involving functional defects (leaks and breakage) in medical devices used during surgical procedures. No illnesses or injuries have been reported in the source text, but the syringes represent a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Medline Industries, LP is recalling multiple procedural kits containing plastic syringes affected by an FDA Safety Alert from March 19, 2024. The recalled kits include tympanoplasty, ear, ENT, nasal, facial, and head/neck surgery packs distributed worldwide.
The plastic syringes in these kits have been identified with leaks, breakage, and quality defects that may pose a risk to patient health during surgical procedures. Syringe failure during active procedures could compromise treatment safety.
Healthcare facilities should review the affected lot numbers and pack numbers in the official FDA recall notice and take appropriate action regarding these products.
The recalled product
- Product
- Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR , Pack Number CDS982016T; 3) MAJOR EAR PACK, Pack Number CMPJ01846O; 4) EAR PACK, Pack Number CMPJ05884J; 5) MZ EAR PACK , Pack Number CMPJ09860D; 6) KIT MAJOR EAR CHRG, Pack
- 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)
- CDS980203S
- Lot Numbers:23DBT154
- Lot Numbers:23HBT797
- Lot Numbers:23JBM122
- Lot Numbers:23LBC884
- Lot Numbers:21CBW683
- CDS982016T
- Lot Numbers:22GBM951
- Lot Numbers:22GBO165
- Lot Numbers:22HBS644
- CMPJ01846O
- Lot Numbers:21LBQ988
- Lot Numbers:22FBV101
- CMPJ05884J
- Lot Numbers:21KBO037
- Lot Numbers:21KBU691
- Lot Numbers:21LBH778
- Lot Numbers:22IBG052
- Lot Numbers:22JBN865
- CMPJ09860D
Distribution
Distribution scope not specified by the agency.
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