Sabraset Administration Sets with AutoClamp; for use with model 6060 multi-therapy pumps only; a prescription, sterile,
FDA device recall Z-0386-05 · posted 2005-01-08 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- A missing platen assembly in the cassette of the solution sets results in the infusion pump being unable to occlude the tubing of the set. This can lead to free-flow of the solution and a possible overdose of medication to the patient.
- Action taken
- Urgent Product Recall letters dated 11/19/04 were sent to the direct accounts on the same date via UPS ground. The accounts were informed that free-flow situations were associated with the listed product codes and lot numbers due to a missing platen assembly in the cassette of the solution sets, which could result in an overdose of medication to the patient. The accounts were requested to stop use of the affected lot numbers and product codes and return the sets to Baxter c/o NNC Group, 2670 Executive Dr., Indianapolis, IN 46241, following the enclosed instructions. Any questions concerning the return process were directed to NCC at 1-866-300-5085. Any medical or technical questions were directed to Baxter at 1-800-422-9837.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 1,355,820 sets
- Distribution
- Nationwide, including Puerto Rico, and internationally to Australia, Belgium, Canada, Hong Kong, Israel, Japan, Singapore, Sweden and Switzerland
- Date initiated
- 2004-11-19
- Date posted
- 2005-01-08
- Date terminated
- 2006-06-28
- Location
- Round Lake, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351 (K002679) | Baxter Healthcare Corp | 2000-09-18 |