Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00221W, 18F x 1.2cm, 10cc, Sterile EO, Bard Access Syst
FDA device recall Z-1113-2009 · posted 2009-04-08 · Terminated
Recall details
- Recalling firm
- C R Bard Inc
- Reason for recall
- Out of specification replacement gastrostomy device was distributed.
- Action taken
- Consignees were notified by "Product Recall" letter distributed on January 7, 2009 via Federal Express overnight mail and asked to check all inventory locations, remove unused affected product and return to Bard Access Systems, Inc (BAS). Customers were also instructed to complete the enclosed Reply Form and Inventory Reconciliation Form and fax it to BAS at 1-801-522-5674. Additional information is available by calling BAS Customer Service at 1-800-290-1689.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KNT
- Quantity affected
- 105 units
- Distribution
- Worldwide Distribution, USA (states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, NH, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV) a
- Date initiated
- 2008-12-22
- Date posted
- 2009-04-08
- Date terminated
- 2010-05-18
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W (K013144) | C.R. Bard, Inc. | 2001-10-19 |