FDA Recall 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.

Recall: Z-1746-2015 · Initiated November 21, 2014

Recall

Recall Number
Z-1746-2015
Event Number
69954
Firm
Becton Dickinson & Co. BD Diagnostic Systems
FEI Number
1119779
Product Code
N/A
Status
Terminated
Root Cause
Process control
Initiated
November 21, 2014
Posted
June 10, 2015
Terminated
January 7, 2016
Address
7 Loveton Circle, Sparks, MD, 21152-0999

Description

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.

Reason

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

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.

Distribution

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.

Quantity

145,860 tubes