Medline Medical Convenience Kits Recalled for Defective Plastic Syringes
Medline is recalling medical convenience kits containing plastic syringes affected by quality issues including leaks and breakage. The defects may pose risks during dental and 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 of medical device kits containing syringes with identified quality defects (leaks, breakage) that may pose a risk to patient health. The defects fit the 'High' severity criterion for risk-of-harm medical products without reported injury or illness.
Plain-English summary
Medline Industries is recalling multiple dental and oral surgery convenience kits containing plastic syringes affected by an FDA Safety Alert issued March 19, 2024. The kits have been distributed worldwide.
The plastic syringes in these kits have identified quality defects including leaks, breakage, and other issues. These defects may pose a risk to patient health when the syringes are used during dental or surgical procedures.
Healthcare facilities and dental offices that have received these kits should be aware of the recall. The recall includes multiple kit types and lot numbers identified by Medline Industries and the FDA.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J ; 2) ORAL SURGERY PACK , Pack Number DYNJ00354K ; 3) ORAL PACK-LF, Pack Number DYNJ0426048L ; 4) ORAL SURGERY PACK-LF, Pack Number DYNJ17477F ; 5) ORAL SURGERY PACK-LF, Pack Number
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leakage
- breakage
- product-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)
- CDS983010J
- Lot Number 22BBC009
- Lot Number 22IBC611
- Lot Number 22IBT150
- Lot Number 22JBR866
- Lot Number 23BBA121
- Lot Number 23GBD710
- Lot Number 23IBK805
- Lot Number 23IBW114
- Lot Number 23LMH952
- DYNJ00354K
- Lot Number 23GMD230
- Lot Number 23HMI535
- Lot Number 23LMC320
- Lot Number 23LMH116
- DYNJ0426048L
- Lot Number 21FLA383
- Lot Number 21GLA406
- Lot Number 21GLB217
- Lot Number 21ILA230
Distribution
Distribution scope not specified by the agency.
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