Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, Injection Site, Male Luer Lock
FDA device recall Z-2837-2011 · posted 2011-07-15 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.
- Action taken
- The firm, Baxter, sent an "Urgent Product Recall" letter dated July 6, 2011 via first class mail to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to locate and remove all affected product from their facility; call Baxter Healthcare's Center for Service at 1-888-229-0001 between 7:00 am and 6:00 pm Central Time, Monday through Friday to return affected product and receive credit; complete and return the attached CUSTOMER REPLY FORM to Baxter via fax at 1-847-270-5457 or scan and email to fca@baxter.com and if you are a dealer, wholesaler or distributor/reseller, notify your customers of this recall. If you have questions regarding the communication, call The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 9,800 sets
- Distribution
- Worldwide distribution: USA (nationwide) including: AL, LA, MO, SD, TX and WV; and country of: Canada.
- Date initiated
- 2011-07-06
- Date posted
- 2011-07-15
- Date terminated
- 2012-04-18
- Location
- Round Lake, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTERLINK(TM) INJECTION SITE (K925126) | Baxter Healthcare Corp | 1993-06-18 |