Recall Z-2327-2012— C.R. Bard, Inc., Urological Division
Class II · Terminated
Class II FDA medical device recall by C.R. Bard, Inc., Urological Division, initiated 2012-06-29, terminated 2013-02-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags.. Reason: Incomplete seal on sterile packages of product..
- Recalling firm
- C.R. Bard, Inc., Urological Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-06-29
- Terminated
- 2013-02-07
- Firm location
- Covington, GA, United States
Product description
Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags.
Reason for recall
Incomplete seal on sterile packages of product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.