Medline Convenience Kits with Plastic Syringes Recalled for Defects
Medline medical convenience kits containing plastic syringes are being recalled due to identified quality issues including leaks and breakage that may pose a risk to patient health. Products were distributed worldwide.
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 medical devices with identified defects (leaks and breakage) that may pose patient safety risks, with no reported illnesses or injuries. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Convenience medical kits containing plastic syringes are being recalled due to quality issues affecting the syringes. The recalled products include multiple kit types with various lot numbers distributed worldwide.
The plastic syringes in these kits are affected by an FDA Safety Alert issued on March 19, 2024. Quality issues have been identified, including leaks, breakage, and other defects that may pose a risk to patient health.
Healthcare providers with the affected Medline Convenience kits should discontinue use and contact Medline Industries for information about the recall and replacement options. A detailed list of affected product codes and lot numbers is available through Medline and the FDA.
Those who may have been affected should consult with their healthcare provider if they experience any unusual symptoms or complications. For additional information, refer to official notices from Medline Industries or the FDA.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) COMPREHENSIVE PROCEDURE PACK, Pack Number 7791 ; 2) LAVH CDS, Pack Number CDS760049AC; 3) LAPAROSCOPY CDS , Pack Number CDS760051AB; 4) LAPAROSCOPY CDS , Pack Number CDS760051AC; 5) LAPAROSCOPY CDS , Pack Number CDS760051AD; 6) ABDOM
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leaking
- breakage
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)
- 7791
- Lot Number 19CDC814
- Lot Number 19EDB234
- Lot Number 19EDC967
- Lot Number 19FDD341
- Lot Number 19GDA594
- Lot Number 19HDC417
- Lot Number 19IDC356
- Lot Number 19KDB323
- Lot Number 19KDB955
- Lot Number 21KDB873
- Lot Number 22CDA330
- Lot Number 22CDA484
- Lot Number 22CDB460
- CDS760049AC
- Lot Number 19KBT844
- Lot Number 20ABJ873
- Lot Number 20BBW737
- Lot Number 20DBL004
- Lot Number 20GBJ882
Distribution
Distribution scope not specified by the agency.
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