FDA Device recall Z-2447-2014
LAPAROSCOPY CHOLE SYSTEM PACK MIAMI METRO CON TENTS: (12) TOWELS CLOTH HUCK BLUE LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER RE…
- FDA Device
- Class I
- terminated
- Published 2014-09-10
On 2014-09-10 the FDA classified a Class I recall of LAPAROSCOPY CHOLE SYSTEM PACK MIAMI METRO CON TENTS: (12) TOWELS CLOTH HUCK BLUE LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER RE… by Customed, citing customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2447-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-05-20 |
| Published | 2014-09-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Customed |
| Distribution | US |
Product
LAPAROSCOPY CHOLE SYSTEM PACK MIAMI METRO CON TENTS: (12) TOWELS CLOTH HUCK BLUE LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SUTURE BAG FLORAL LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) BULB SYRINGE 60cc LIF (1) BLADE SURGICAL #10 STAINLESS STEEL (2) SHEET% 60" X 77" DRAPE REINFORCED LIF (10) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) BLADE SURGICAL #15 CARBON STEEL (1) TUBE SUCTION CONNECT Y." X 12' LIF (1) BAG GLASSINE PLAIN (1) CAUTERY TIP POLISHER LIF (1) DRAPE LAP. ABDOMINAL WITH POUCH 102" X 122" X 78" LIF (1) PK. STRIP STERI CLOSURE W' X 4" LIF (1) SKIN MARKER INK WITH 8/LABEL/TIME OUT/RULER L/F (1) CORD LAPAROSCOPY MONOPOLAR FOOD SWICHING (1) COUNTER NEEDLE BLADE 30c MAG/FOAM (1) TIME OUT BEACON NON WOVEN LIF (1) GOWN XL SMS IMPERVIOUS REINFORCED LIF (1) GOWN SURG. REINFORCED X LARGE TOWEL/WRAP LIF (1) TOWEL ABSORBENT 15" X 20" LIF (1) BLADE SURGICAL #11 CARBON STEEL (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT LIF (1) YANKAUER OPEN TIP CLEAR WITHOUT C IV LIF ATTACHED PACK WITH THE FOLLOWING STERILE COMPONENT: (1) ACTIFOG WITH/FOAM PAD SOLUTION LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Reason
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Identifiers
| code_info | Product code 900-2270,1 lot 112125073 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2447-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.