Baxter Extension Sets with PosiFlow Access Device for IV Access; product codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2
FDA device recall Z-0854-05 · posted 2005-06-01 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.
- Action taken
- Urgent Device Correction letters dated 3/3/05 were sent to the direct accounts via first class mail, to the attention of the Director of Nursing. The accounts were informed of the field reports received concerning the PosiFlow Access Device and IV sets containing the PosiFlow device and the changes made to the directions for use and in-service training materials to correct the problems. The accounts were requested to complete and fax back to Baxter at 847-270-5457 the enclosed customer reply form, acknowledging the receipt and dissemination of the information to their staff. Wholesalers were requested to notify their customers. Any questions were directed to the Center for One Baxter at 1-800-422-9837.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- not known
- Distribution
- Nationwide
- Date initiated
- 2005-03-03
- Date posted
- 2005-06-01
- Date terminated
- 2006-05-11
- Location
- Round Lake, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS (K964918) | Critical Device Corp. | 1997-04-14 |
| LOW PLASTICIZER ADMINISTRATION SETS (K791496) | Travenol Laboratories, S.A. | 1980-04-08 |