Recall Z-0098-04 ยท FMI Needle, Hypodermic, Single Lumen
Bard Access Systems, Inc
Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic.
| Date | Nov 6, 2003 (initiated Sep 23, 2003) |
| Status | Terminated |
| Reason | Sterility of product is compromised by open seals in packaging. |
| Root cause | Other |
| Action | Recall letters were sent to US customers on September 23, 2003. International customers were sent communication on September 24, 2003. |
| Quantity | 106,500 units |
| Distribution | Nationwide. Foreign distribution to Australia, Brazil, Canada, China, Hong Kong, India, Japan, Malaysia, Singapore, Taiwan, Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K863606 | BUTTERFLY NON-CORING NEEDLE SET Cormed, Inc., Sub. C.R.Bard, Inc., Dec 18, 1986 |