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Terminated

BD Vacutainer Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x x 12. Catalog no 367364

FDA Recall Z-1533-2018 · Posted None

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeJKA
Date Initiated2018-03-20
Date Terminated2020-04-20

Reason for Recall

Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.

Firm Action

Immediately review your inventory for the specific Catalog (Ref) and lot numbers, and quarantine product subject to the recall. Immediately discontinue the distribution of the affected product. If you have inventory of the recalled product, please complete the attached Business Response Form and return the recalled product following the enclosed packing instruction. This is required so that BD may process your product replacement. If you do not have the recalled product, please complete the attached Business Response Form as well so that BD receives an acknowledgement of your receipt of this recall notification

Root Cause

Material/Component Contamination

Distribution Pattern

US (Nationwide) Canada, Kuwait, Guyana, Guatemala, Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland and Lithuania

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030573BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341Bd Vacutainer Systems Preanalyical Solutions · 2003-05-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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