BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.
FDA Recall Z-1747-2015 · Posted 2015-06-10
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Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeN/A
Date Initiated2014-11-21
Date Terminated2016-01-07
Product Quantity92,710 units
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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