Medline Convenience Kits with Defective Plastic Syringes Recalled
Medline is recalling Convenience kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and quality defects that may pose a risk to patient safety.
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 a Class II medical device recall involving surgical kits where documented quality issues—leaks and breakage—pose a risk of patient harm. No illnesses or injuries have been reported in the source text. This meets the rubric criterion for 'High': risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling Convenience kits labeled as Gamma Nail CDS-LF (Pack Number CDS983505K) that have been distributed worldwide. The plastic syringes in these kits are affected by issues identified in an FDA Safety Alert issued on March 19, 2024, and may develop leaks, breakage, or other quality defects during use.
These defective syringes may pose a risk to patient health. Healthcare facilities and individuals who received kits with the affected lot numbers (23HBC802, 23JBQ026, 23LBQ345, 24ABI223) should stop using them immediately.
If you have received affected kits, contact your distributor or Medline Industries for instructions on return, replacement, or disposal.
The recalled product
- Product
- Medline Convenience kits, labeled as: GAMMA NAIL CDS-LF , Pack Number CDS983505K
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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 (5)
- CDS983505K
- Lot Number 23HBC802
- Lot Number 23JBQ026
- Lot Number 23LBQ345
- Lot Number 24ABI223
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 81 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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