Recall Z-1478-2023 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
Labories Medical Technologies
injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge
| Date | Apr 28, 2023 (initiated Feb 7, 2023) |
| Status | Open, Classified |
| Reason | The packaging may be damaged, compromising the sterile barrier. |
| Root cause | Process control |
| Action | A customer letter dated February 7, 2023 was issued to impacted consignees. The letter asks consignees to examine their inventory for affected product lots and to complete a response card to the recalling firm. Return of impacted product will be coordinated with Laborie Medical Technologies. |
| Quantity | 415,480 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090830 | LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP Laborie Medical Technologies, Ltd., Jul 21, 2009 |