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.
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: 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
- Hazard
- non-sterile
- infection-risk
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.
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