Ring, Laparotomy
FDA product code FHI · Class I (low risk) · 21 CFR 876.4730 · Gastroenterology, Urology
0510(k) clearances
0PMA approvals
10recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2384-2014 Class I | PREMIUM LAPAROTOMY PACK - CUSTOMED- (1) DRAPE T LAPAROT 102" X 78" X 121" (1) GOWN XL…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2364-2014 Class I | LAPAROTOMY PACK- (1) MAYO STAND COVER REINFORCED LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2353-2014 Class I | LAPAROTOMY PACK - CONTENTS: ( 1) GOWN XL SMS IMPERVIOUS REINFORCED LIF ( 1) MAYO STAND…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2330-2014 Class I | LAPAROTOMY BASIC PACK- CUSTOMED- (1) TABLE COVER REINFORCED 44" X 78" LIF (1) COVER MAYO…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2326-2014 Class I | MINOR LAPAROTOMY PACK - (1) DRAPE T LAPAROTOMY (1) BAG SUTURE FLORAL LIF (4) DRAPE…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2316-2014 Class I | LAPAROTOMY PACK - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDPAD (I)…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2315-2014 Class I | LAPAROTOMY PACK - (I) SURGICAL BLADE #10 S/STEEL ( I) UTILITY BOWL 32oz (I) UTILITY BOWL…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2312-2014 Class I | LAPAROTOMY PACK - CUSTOMED- (1) BAG SUTURE FLORAL (2) TOWEL ABSORBENT 15" X 20" (1) MAYO…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2307-2014 Class I | Customed Laparotomy Pack , convenience pack include multiple components: drape laparot.…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |
| Z-2305-2014 Class I | Customed Major Laparotomy Pack , convenience pack include multiple components: Mayo…Customed has determined that there is the possibility that packaging integrity may be compromised on… | Customed, Inc | 05/20/2014Terminated |