Recalls / —
—#142618
Product
REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation.
- FDA product code
- KYZ — Syringe, Irrigating (Non Dental)
- Device class
- Class 1
- Medical specialty
- General Hospital
- Affected lot / code info
- Lot Number NGZE1190
Why it was recalled
Report by a customer of an open package seal.
Root cause (FDA determination)
Packaging process control
Action the firm took
BMD sent an Urgent Medical Product Recall letter to each of the customers via FedEx with proof of delivery notice. The leter identified the affected product, problem and actions to be taken. All consignees were instructed to carry out the recall to the user level. The letter included a Recall and Effectiveness Check Form which was to be returned to Bard.
Recalling firm
- Firm
- C.R. Bard, Inc.
- Address
- 8195 Industrial Blvd NE, Covington, Georgia 30014-1497
Distribution
- Distribution pattern
- US Nationwide Distribution - in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, MD, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, PA, SC, TN, TX, VA, WA, WV, and Puerto Rico
Timeline
- Recall initiated
- 2016-01-04
- Posted by FDA
- 2016-02-16
- Terminated
- 2017-06-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #142618. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.