The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0204-2022·Announced 2021-11-17

McKesson Safety Blood Collection Needles Recalled for Safety Mechanism Defect

McKesson PREVENT HT Safety Blood Collection Needles are being recalled due to potential difficulty in activating the safety mechanism. The recall affects needles distributed nationwide, including specific lot numbers with expiration dates through May 2025.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 involving a defect in a safety mechanism on a blood collection needle, which is a risk-of-harm product. No illnesses or injuries have been reported, which prevents a higher score, but the safety feature defect on a sharps device presents potential for harm to healthcare workers.

Plain-English summary

McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch (MFR # 16-NBC21GS), manufactured by Zhejiang Kindly Medical Devices Co., Ltd., are being recalled.

The recall is due to potential difficulty in safety mechanism activation. The safety features on affected units may not operate as intended, which could compromise the protective function of the needles.

The affected lots were distributed nationwide. Specific lot numbers include CDI11-01, CDKI11-02, CKI12-01, CKDJ01-01, CKDJ05-01, and CKDJ06-01, with expiration dates ranging from October 2024 through May 2025.

Healthcare facilities and providers using these needles should stop use of the affected lots immediately and contact Zhejiang Kindly Medical Devices Co., Ltd. or McKesson for instructions on returning or replacing the product.

The recalled product

Product
McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS

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 (6)

  • lot numbers / Expiration Date: CDI11-01 / Exp. Date 2024-10-01
  • CDKI11-02 / Exp. Date 2024-10-02
  • CKI12-01 / Exp. Date 2024-11-01
  • CKDJ01-01 / Exp. Date 2024-12-01
  • CKDJ05-01 / Exp. Date 2025-04-01
  • CKDJ06-01 / Ex. Date 2025-05-01.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Zhejiang Kindly Medical Devices Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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