Device recall
Z-2491-2014: Breast Pack MRT, code 900-2658, contains: ( 1) BULB SYRINGE 60cc (2) GOWN SOFT…
FDA device recall · Class I · Customed, Inc
Key facts
| Recall number (Z-number) | Z-2491-2014 |
|---|---|
| Recall event | 68536 |
| Product | Breast Pack MRT, code 900-2658, contains: ( 1) BULB SYRINGE 60cc (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK ( 1) NEEDLE and BLADE COUNTER 20c FOAM/MAG ( 1) UTILITY BOWL QUART 32oz ( 1) MAYO STAND COVER REINFORCED ( 1) TABLE COVER… |
| Product code | LRO |
| Recalling firm | Customed, Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 14, 2017 |
| FEI number | 2648727 |
At a glance
- None Linked 510(k)s
- 100–999 Products in the same recall event
- 1,000+ Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database