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Recall Observatory FDA recall evidence

Device product

BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.

Z-1747-2015

November 21, 2014

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 69954
Status
Terminated
Classification
Class II
Quantity
92,710 units
Official record key
device-enforcement:Z-1747-2015

Official wording

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

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

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.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Excessive oxidation may affect the viability of anaerobic microorganisms