Z-1746-2015 Class II Terminated
FDA device recall Z-1746-2015 was initiated by Becton Dickinson & Co. on Nov 21, 2014 and is designated Class II. Reason for recall: The products may exhibit indications of excessive oxidation. Excessive oxidation may affect the viability of anaerobic microorganisms. The recall status is terminated (terminated Jan 7, 2016). Affected quantity: 145,860 tubes.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 17, 2015
- Initiation Date
- Nov 21, 2014
- Termination Date
- Jan 7, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 145,860 tubes
Product 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 for Recall
The products may exhibit indications of excessive oxidation. Excessive oxidation may affect the viability of anaerobic microorganisms.
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.
Code Information
Part/Cat No. Lot / Serial No.Date of Mfr Exp. Date 221606 4042455 2/25/2014 2/5/2015 221606 4067180 3/18/2014 3/5/2015 221606 4087204 4/10/2014 3/25/2015 221606 4124702 5/8/2014 4/24/2015 221606 4161968 7/7/2014 6/12/2015 221606 4181959 7/14/2014 7/3/2015 221606 4032407 2/14/2014 1/29/2015 221606 4042069 2/17/2014 2/4/2015
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1746-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026