Medline non-sterile syringes recalled for out-of-specification piston configurations
Medline non-sterile syringes (Model 91880) are being recalled because the piston sizes and configurations exceed what the manufacturer submitted for FDA approval. No illnesses or injuries 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: FDA Class II medical device recall. Syringes with out-of-specification dimensions represent risk-of-harm products, as improper dimensions could affect proper function and use. No illnesses or injuries have been reported, placing this at the maximum score for theoretical hazards.
Plain-English summary
Medline non-sterile syringes (Model 91880, 10ml capacity) manufactured by Jiangsu Shenli Medical Production Co., Ltd. are being recalled by the U.S. Food and Drug Administration. The recall affects approximately 44,800 units distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
The FDA determined that the piston syringe sizes and configurations exceed the range of devices cleared under the manufacturer's 510(k) pre-market notification. In other words, the syringes do not match the specifications that were submitted to and approved by the FDA.
Customers who have received affected units should stop using them and contact Medline for instructions on return or replacement. The affected lot codes are 63720120007, 63721110003, 63721120004, 63722010001, 63722020002, 63722030002, 63722060003, 63722070002, 63723100003, 63723110005, and 63723120002.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L BLUE Model/Catalog Number: 91880 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- specification-mismatch
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 (11)
- Lot Code: LOT: 63720120007
- 63721110003
- 63721120004
- 63722010 001
- 63722020002
- 63722030002
- 63722060003
- 63722070002
- 63723100003
- 63723110005
- 63723120 002
Distribution
Distributed nationwide across the United States.
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