Barrier Hip Sheet with Side Pockets
FDA device recall Z-1137-03 · posted 2003-08-14 · Terminated
Recall details
- Recalling firm
- Molnlycke Health Care Inc
- Reason for recall
- pouch may tear which could result in contamination of sterile field
- Action taken
- The recalling firm issued recall letters dated 7/9/03 to their direct accounts informing them of the problem/reason for recall, the need to return the product and to contact their customers regarding the recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- KKX
- Quantity affected
- 2714 units
- Distribution
- The products were shipped to distributors, hospitals, and sales representatives nationwide. The product was also shipped to dealers in Australia, New Zealand, Canada, and Belgium.
- Date initiated
- 2003-07-14
- Date posted
- 2003-08-14
- Date terminated
- 2003-11-10
- Location
- Newton Pa, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BARRIER HIP PACK W/ FABRIC 450 (K780282) | Surgikos, Inc. | 1978-02-28 |