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Terminated

BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A Cul tubes, jars and vials contain a reduced transport medium and are intended to maintain the viability of anaerobic, facultative and aerobic microorganisms during transport from the patient to the laboratory. Sterile packages are for collection of specimens in clean areas; e.g., surgical suites.

FDA Recall Z-1746-2015 · Posted 2015-06-10

Recall StatusTerminated
Product CodeN/A
Date Initiated2014-11-21
Date Terminated2016-01-07
Product Quantity145,860 tubes

Reason for Recall

The products may exhibit indications of excessive oxidation. Excessive oxidation may affect the viability of anaerobic microorganisms.

Firm Action

BD Diagnostic Systems sent an Urgent Product Recall letter dated December 2014 to all affected customers. Recall notification was initiated on November 21, 2014, the notification was sent by fax and letters by UPS. Customer notification for the expansion of the recall was initiated on December 18, 2014, the notification was sent by fax and letters by UPS. For questions regarding this recall call 800-638-8663.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.

Official Source

View FDA Recall →

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

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