Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and contains a variety of co
FDA device recall Z-0753-03 · posted 2003-04-22 · Terminated
Recall details
- Recalling firm
- Windstone Medical, Inc.
- Reason for recall
- Product has latex free symbol on package, yet contains latex components.
- Action taken
- On 3/25/03 the firm contacted their customers by telephone. This was followed by a letter dated 3/25/03. Enclosed with the letter is a response form for the customer to fill out and return to the firm. Product is to be returned to the firm.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 8
- Distribution
- The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.
- Date initiated
- 2003-03-25
- Date posted
- 2003-04-22
- Date terminated
- 2003-09-09
- Location
- Billings, MT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIO-PAK BASIC PUMP PACK (K923231) | Cardio-Med-Associates, Inc. | 1993-07-09 |
| CARDIO-PAK LAPAROTOMY PACK (K923233) | Cardio-Med-Associates, Inc. | 1993-03-20 |
| CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS (K902475) | Cardio-Pak | 1990-12-03 |