Medline Non-Sterile Syringes Model 91876 Recalled for Outside Specification Sizes
Medline non-sterile syringes (Model 91876) are being recalled because certain lot codes contain sizes and configurations that exceed the range cleared by the FDA. No injuries or illnesses have been reported.
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 a non-sterile device manufactured outside its cleared specifications. No injuries or illnesses have been reported, but devices used outside their tested specifications present potential contamination risk.
Plain-English summary
Medline non-sterile syringes (Model 91876) with certain lot codes are being recalled. These devices are manufactured in sizes and configurations that exceed the range cleared by the FDA in the company's 510(k) approval.
The recalled syringes have been distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia. Approximately 17,280 units are affected, identified by specific lot codes provided by the manufacturer.
The recall is being issued to address the manufacturing deviation from approved specifications. Customers who received these products should contact Jiangsu Shenli Medical Production Co., Ltd. for guidance on return or replacement.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR CNTR 10ML L/L YELLOW Model/Catalog Number: 91876 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device
- Hazard
- regulatory-non-compliance
- contamination-risk
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 (14)
- Lot Code: LOT: 63721010004
- 63721040002
- 63721050002
- 63721080 003
- 63721100001
- 63721100003
- 63721110001
- 63722010001
- 63722030001
- 63722050001
- 63722100 003
- 63723030001
- 63723060005
- 63723070001
Distribution
Distributed nationwide across the United States.
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