Medline procedural kits recalled due to syringe quality issues
Medline is recalling specific procedural kits because they contain plastic syringes with leaks or breakage risks that may pose a threat 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: The recall is classified as FDA Class II, and the source text states that quality issues 'may pose a risk to patient health' without reporting specific injuries or illnesses, which aligns with the High severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling specific procedural kits labeled as SR C SECTION (Pack Numbers DYNJ908584 and DYNJ908584A) and C SECTION (Pack Number DYNJ909098). The recall is limited to specific lot numbers listed in the agency's structured data, including 22DBL462, 22JBS694, and 23CBQ227 for the DYNJ908584 pack, among others.
The recall is being conducted because these medical convenience kits contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The syringes have been identified as having leaks, breakage, and other quality issues that may pose a risk to patient health.
The affected products were distributed worldwide. Healthcare providers and consumers should check their inventory for the specific pack numbers and lot numbers listed in the recall notice. If these products are found, they should be removed from use and returned to Medline or the distributor according to the instructions provided by the company.
The recalled product
- Product
- Medline procedural kits labeled as: 1) SR C SECTION, Pack Number DYNJ908584; 2) SR C SECTION, Pack Number DYNJ908584A; 3) C SECTION, Pack Number DYNJ909098
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedural 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 (18)
- DYNJ908584
- Lot Numbers: 22DBL462
- Lot Numbers: 22JBS694
- Lot Numbers: 23CBQ227
- Lot Numbers: 23FBT227
- DYNJ908584A
- Lot Numbers: 23HBQ685
- Lot Numbers: 23JBT134
- Lot Numbers: 23LBE682
- Lot Numbers: 24CBH741
- DYNJ909098
- Lot Numbers: 22LBS559
- Lot Numbers: 23EBQ496
- Lot Numbers: 23FBG194
- Lot Numbers: 23GBK039
- Lot Numbers: 23GBQ855
- Lot Numbers: 23IBK300
- Lot Numbers: 23IBQ772
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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