Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic.
FDA device recall Z-0098-04 · posted 2003-11-06 · Terminated
Recall details
- Recalling firm
- Bard Access Systems, Inc
- Reason for recall
- Sterility of product is compromised by open seals in packaging.
- Action taken
- Recall letters were sent to US customers on September 23, 2003. International customers were sent communication on September 24, 2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- FMI
- Quantity affected
- 106,500 units
- Distribution
- Nationwide. Foreign distribution to Australia, Brazil, Canada, China, Hong Kong, India, Japan, Malaysia, Singapore, Taiwan, Venezuela.
- Date initiated
- 2003-09-23
- Date posted
- 2003-11-06
- Date terminated
- 2004-03-18
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BUTTERFLY NON-CORING NEEDLE SET (K863606) | Cormed, Inc., Sub. C.R.Bard, Inc. | 1986-12-18 |