injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 ga
FDA device recall Z-1478-2023 · posted 2023-04-28 · Open, Classified
Recall details
- Recalling firm
- Labories Medical Technologies
- Reason for recall
- The packaging may be damaged, compromising the sterile barrier.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FBK
- Quantity affected
- 415,480 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2023-02-07
- Date posted
- 2023-04-28
- Location
- Portsmouth, NH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP (K090830) | Laborie Medical Technologies, Ltd. | 2009-07-21 |