Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Len
FDA device recall Z-1684-2013 · posted 2013-07-10 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.
- Action taken
- Baxter sent an Urgent Product Recall letter dated May 15, 2013 to all affected custorners. The letter identified the affected product, problem and actions to be taken. Customers were requested to remove all affected products and return for credit by contacting Baxter Healthcare Center for Service at 888-229-0001. Customers were instructed to complete the attached Customer Reply Form and return it to Baxter by either faxing to 224-270-5457 or scanning and e-mailing the reply form to fca@baxter.com
- Root cause
- Packaging
- Status
- Terminated
- Product code
- LJH
- Quantity affected
- 249,576 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2013-05-15
- Date posted
- 2013-07-10
- Date terminated
- 2015-06-16
- Location
- Deerfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS (K960787) | Baxter Healthcare Corp | 1996-05-14 |