Recall Z-1177-06 ยท HET Laparoscope, Gynecologic (And Accessories)
Stryker Endoscopy
Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set, Model Numbers: 620-030-201, 620-030-301
| Date | Jun 27, 2006 (initiated Jun 2, 2006) |
| Status | Terminated |
| Reason | Device for which sterility may be compromised as evidenced by a loss of package integrity. |
| Root cause | Packaging process control |
| Action | On 6/2/06, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned. |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943508 | INSUFFLATOR TUBING WITH FILTER Stryker Endoscopy, Nov 17, 1994 |