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U.S. Department of Health and Human Services

Class 2 Device Recall BBL Port A Cul tubes with Swabs Sterile

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  Class 2 Device Recall BBL Port A Cul tubes with Swabs Sterile see related information
Date Initiated by Firm November 21, 2014
Date Posted June 10, 2015
Recall Status1 Terminated 3 on January 07, 2016
Recall Number Z-1747-2015
Recall Event ID 69954
Product Classification Patient sample collection containers - Product Code N/A
Product BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.
Code Information Part/Cat No. Lot / Serial No.Date of Mfr Exp. Date  221607 4067181 3/19/2014 3/5/2015 221607 4083274 4/3/2014 3/20/2015 221607 4124706 5/9/2014 4/24/2015 221607 4127564 5/22/2014 5/1/2015 221607 4170891 7/8/2014 6/19/2015 221607 4006235 2/18/2014 12/26/2014 221607 4028420 2/19/2014 1/21/2015
Recalling Firm/
Manufacturer
Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact Technical Services Department
800-638-8663
Manufacturer Reason
for Recall
The products may exhibit indications of excessive oxidation. Excessive oxidation may affect the viability of anaerobic microorganisms.
FDA Determined
Cause 2
Process control
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.
Quantity in Commerce 92,710 units
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.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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