***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites Male L
FDA device recall Z-2613-2014 · posted 2014-09-09 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp
- Reason for recall
- Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the drip chamber. Affected product codes are: 2C7564, 2C8864 and 2H8864.
- Action taken
- Action to be taken if product was purchased directly from Baxter: Baxter is requesting that you take the following actions: 1. Locate and remove all affected product from your facility (the product code and lot number can be found on the individual product package or shipping carton). 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling. 3. Complete the enclosed customer reply form, and return it to Baxter by either fax Or scanned e-mail. 4. If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please conduct a recall with your end-user customers in accordance with your customary procedures. Baxter distributed this product to customers between September 27, 2013, and April 25, 2014. Action to be taken if the products were purshased from a distributor or re-seller. 1. Locate and remove all affected product from your facility (the product code and lot number can be found on the individual product package or shipping carton). 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your ship-to account number ready when calling. 3. Follow your supplier's reply and recall process. Please do not return the customer reply form to Baxter.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 234196
- Distribution
- Nationwide Distribution.
- Date initiated
- 2014-07-14
- Date posted
- 2014-09-09
- Date terminated
- 2016-03-15
- Location
- Deerfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S (K123874) | Baxter Healthcare Corp | 2013-01-10 |