Safety Blood Collection Needle Recalled for Safety Mechanism Activation Issues
Zhejiang Kindly Medical Devices is recalling Henry Schein Safety Blood Collection Needles due to potential difficulty activating the safety mechanism. Affected lot numbers distributed nationwide.
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 medical device recall with a potential safety mechanism defect but no reported injuries or illnesses. The product presents a risk of harm (needle stick injuries from failed safety mechanism) without yet-reported adverse events, meeting the criteria for High severity.
Plain-English summary
Zhejiang Kindly Medical Devices Co., Ltd. is recalling Henry Schein Safety Blood Collection Needles (21 gauge, 1 1/4 inch, model REF 570-2067). The recalled product includes needles with lot numbers 20201030 (expiration date 2025-10-29) and 20201210 (expiration date 2025-12-09), distributed nationwide in the United States.
The needles are being recalled due to potential difficulty in activating the safety mechanism. This defect could affect the product's ability to protect healthcare workers from needle stick injuries.
Healthcare facilities and professionals using these needles should immediately stop using the affected lot numbers and contact their supplier for instructions on return or replacement.
The recalled product
- Product
- HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 350*210*350mm
- Manufacturer
- Zhejiang Kindly Medical Devices Co., Ltd.
- Hazard
- device-malfunction
- needle-stick-injury
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 (2)
- Lot Numbers / Expiration Date: 20201030 / Exp. Date 2025.10.29
- 20201210 / Exp. Date 2025.12.09.
Distribution
Distributed nationwide across the United States.
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