Medline Non-Sterile Syringes Recalled for Out-of-Specification Configurations
Medline is recalling 124,800 non-sterile syringes (model 91838) distributed nationwide because their configurations fall outside specifications cleared by the FDA under the firm's 510(k) approval.
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 recall with no reported illnesses or injuries. The FDA's Class II designation indicates the agency has determined that serious adverse health consequences are possible, though no actual incidents have been documented.
Plain-English summary
Medline (manufactured by Jiangsu Shenli Medical Production Co., Ltd.) is recalling 124,800 non-sterile syringes without needles, model 91838 (SYR 20ML L/L WHITE). These syringes were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
The syringes are being recalled because their sizes and configurations fall outside the range of products cleared under the manufacturer's 510(k) premarket approval. The configurations distributed were not authorized by the FDA.
The syringes were shipped through major U.S. ports and destinations including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk. Lot codes subject to recall include 63721010001, 63722020002, 63722030001, 63722050001, 63722080002, 63722090002, 63722100003, 63723070001, 63723080001, 63723110001, and 63723120002.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE Model/Catalog Number: 91838 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device
- Hazard
- clearance-violation
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: 63721010001
- 63722020002
- 63722030001
- 63722050001
- 63722080002
- 63722090002
- 63722100003
- 63723070001
- 63723080001
- 63723110001
- 63723120002
Distribution
Distributed nationwide across the United States.
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