Medline non-sterile syringes recalled for out-of-range configuration variations
Medline's non-sterile syringes (Model 91877) are recalled because their sizes and configurations exceed what was approved under the firm's 510(k) clearance. The regulatory non-compliance affects 3,840 units distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is regulatory non-compliance where devices' sizes and configurations fall outside the approved range, constituting a product defect; however, the source does not identify or report any actual harm.
Plain-English summary
The recalled product is a non-sterile syringe without needle (Model 91877, brand Medline) manufactured by Jiangsu Shenli Medical Production Co., Ltd. The U.S. Food and Drug Administration (FDA) determined that the syringes' sizes and configurations fall outside the range of designs approved under the firm's 510(k) submission.
When a device's physical characteristics differ from the approved design, the device may not perform as intended or meet the safety standards verified during FDA approval. This regulatory non-compliance creates potential risks because the unapproved configurations were not tested or validated for safety.
The recall affects 3,840 units with lot codes 63721080004, 63721090001, 63722090002, 63723030001, and 63723050001. Distribution was nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia. For information about this recall, affected parties should contact Jiangsu Shenli Medical Production Co., Ltd.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L YELLOW LIDO Model/Catalog Number: 91877 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- product-defect
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)
- Lot Code: LOT: 63721080004
- 63721090001
- 63722090002
- 63723030 001
- 63723050001
Distribution
Distributed nationwide across the United States.
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