The Recall Desk
HighFDA (Devices)·Z-0002-2022·Announced 2021-10-13

Bone Marrow Aspiration Needle Protector Can Dislodge, Posing Needle-Stick Risk

Bard Peripheral Vascular is recalling REF TIN3015 bone marrow aspiration needles because the needle protector can become fully dislodged, exposing the needle and creating needle-stick injury risk for healthcare workers.

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 structural safety-mechanism defect that creates needle-stick injury hazard for healthcare personnel. No illnesses or injuries have been reported, qualifying it as a risk-of-harm product without reported injury per the rubric.

Plain-English summary

Bard Peripheral Vascular Inc. is recalling REF TIN3015 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needles for single use due to a defect in the needle protector mechanism. The protective cover can become fully dislodged during use, exposing the infusion needle and creating a potential needle-stick injury hazard for medical personnel.

This product has been distributed worldwide, including to healthcare facilities across all U.S. states and to multiple international locations including Canada, Mexico, Australia, Japan, India, the Netherlands, United Arab Emirates, and others. Affected units span multiple lot and serial numbers with expiration dates ranging from June 2021 through June 2025.

Healthcare facilities and medical personnel using this product should immediately stop using all affected lot numbers and contact Bard Peripheral Vascular Inc. for instructions on product return or replacement. Check your facility's inventory against the complete list of recalled lot numbers and expiration dates to identify which units are affected.

No illnesses or injuries from this defect have been reported. However, needle-stick injuries pose a serious occupational hazard for healthcare workers.

The recalled product

Product
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Injection / Aspiration Needle
Hazard
  • needle-stick
  • device-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 (20)

  • Lot/Serial Number - Exp. Date: 963162 6/30/2021
  • 967672 6/30/2021
  • 978229 7/31/2021
  • 986594 7/31/2021
  • 988075 7/31/2021
  • 991067 8/31/2021
  • 994373 8/31/2021
  • 996570 8/31/2021
  • 998004 8/31/2021
  • 998332 8/31/2021
  • 1000061 8/31/2021
  • 1004858 9/30/2021
  • 1005204 9/30/2021
  • 1007650 9/30/2021
  • 1010791 9/30/2021
  • 1013939 9/30/2021
  • 1017379 10/31/2021
  • 1035580 11/30/2021
  • 1035581 11/30/2021
  • 1038740 11/30/2021

Distribution

Distributed nationwide across the United States.

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