The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2249-2021·Announced 2021-08-18

Bard Bone Marrow Aspiration Needles Recalled for Incomplete Packaging Seals

Bard Peripheral Vascular is recalling Illinois Bone Marrow Aspiration/Intraosseous Infusion Needles due to incomplete or open packaging seals that could compromise sterility. Approximately 1,200 devices are affected.

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 recall with no reported illnesses, injuries, or hospitalizations. The hazard—potential non-sterility from packaging defects—poses infection risk but remains theoretical without confirmed patient harm.

Plain-English summary

Bard Peripheral Vascular Inc is recalling the TIN3018 (18G x 79mm) and TIN3015 (15G x 79mm) Illinois Bone Marrow Aspiration/Intraosseous Infusion Needles. The needles have been recalled due to complaints regarding incomplete or open packaging seals that could allow products to become non-sterile.

These devices are used for bone marrow aspiration and intraosseous infusion procedures. If packaging seals are compromised, the sterile field may be violated, potentially exposing patients to infection risk.

Approximately 1,200 devices are affected. The recalled products were distributed nationwide across the United States (Arizona, Connecticut, DC, Florida, Illinois, Massachusetts, Michigan, Missouri, New York, Oklahoma, Texas, and Virginia) and internationally (Australia, Belgium, China, EMEA, Japan, Mexico, Saudi Arabia, Singapore, and Taiwan). The affected devices can be identified by model numbers TIN3018 (UDI 10885403043819) or TIN3015 (UDI 10885403043796) with expiration date 241031 and specific serial numbers.

Consumers and healthcare providers who have these needles should stop using them immediately and contact Bard Peripheral Vascular Inc for instructions on return, refund, or replacement.

The recalled product

Product
TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Surgical Instruments
Hazard
Affected units
1,200

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 (4)

  • Catalog Number/UDI: TIN3018/(01)10885403043819(17)241031(10)0001330956
  • TIN3015/(01)10885403043796(17)241031(10)0001331229
  • Serial Numbers: 0001330956
  • 0001331229

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Bard Peripheral Vascular Inc 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 3 products in this recall →

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