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FDA (Device enforcement)Recalled 2021-06-23class ii

Bard Peripheral Vascular Inc: TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm

Is my product affected?

TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm

  • UPC 10885403043819
  • UPC 10885403043796

Check against the official notice below — it lists the full affected range.

What happened

Bard Peripheral Vascular Inc. has recalled two models of bone marrow aspiration/intraosseous infusion needles due to complaints about incomplete or open packaging seals that could compromise sterility. The recalled products are the TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm and the TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm. A total of 1,200 devices were distributed nationwide across 12 U.S. states (Arizona, Connecticut, DC, Florida, Illinois, Massachusetts, Michigan, Missouri, New York, Oklahoma, Texas, and Virginia) as well as internationally to Australia, Belgium, China, Japan, Mexico, Saudi Arabia, Singapore, and Taiwan.

The affected products are identified by specific catalog numbers, UDIs, and serial numbers: TIN3018 with serial number 0001330956 and TIN3015 with serial number 0001331229, both with an expiration date of October 31, 2024. The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.

Details from the source

Reason for recall: Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile. Distribution: U.S Nationwide Distribution in the states of .: AZ, CT, DC, FL, IL, MA, MI, MO, NY, OK, TX, and VA O.U.S.: Australia, Belgium, China, EMEA, Japan, Mexico, Saudi Arabia, Singapore, Taiwan Quantity: 1,200 device Lot/code info: Catalog Number/UDI: TIN3018/(01)10885403043819(17)241031(10)0001330956; TIN3015/(01)10885403043796(17)241031(10)0001331229; Serial Numbers: 0001330956; 0001331229;

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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