FDA Device recall Z-2378-2014
LAPAROSCOPY OB GYN PACK - (1) DURAPREP SURGICAL SOLUTION 26ML LIF (1) SHEET T LAPAROSCOPY SMS LIF (2) DRAPE UTILITY WITH TAPE LIF (1) DRAPE…
- FDA Device
- Class I
- terminated
- Published 2014-09-10
On 2014-09-10 the FDA classified a Class I recall of LAPAROSCOPY OB GYN PACK - (1) DURAPREP SURGICAL SOLUTION 26ML LIF (1) SHEET T LAPAROSCOPY SMS LIF (2) DRAPE UTILITY WITH TAPE LIF (1) DRAPE… 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-2378-2014 |
| 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 OB GYN PACK - (1) DURAPREP SURGICAL SOLUTION 26ML LIF (1) SHEET T LAPAROSCOPY SMS LIF (2) DRAPE UTILITY WITH TAPE LIF (1) DRAPE SHEET 41" X 58" SMS LIF (4) ABSORBENT TOWELS 15" x 20" LIF (1) PVP TRIPLE SWABSTICK IODOPHOR (1) DRAPE LASER CAMERA W/EL 6" X 96" (1) TUBE SUCTION CONNECT.%" X 12' LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (1) SURGICAL BLADE #11 CARBON STEEL (1) TABLE COVER 44" X 78" REINFORCED LIF (1) TEGADERM TRANS DRESSING 6" X 8" (2) LEGGINS WITH 7" CUFF 30" X 42" (10) GAUZE SPONGES 4" X 4" 12PLY XRD (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (1) TUR CYSTO IRRIGATION SET 79" (1) FOLEY CATHETER 16FR 2WAY, 5CC (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (2) GOWN IMPERVIOUS EXTRA REINF XLG LIF (1) TROCAR ENDO. XCEL DILATING TIP 5MM (K5LT) (1) PNEUMO INSUFLAT NEEDLE 150MM LUER LOCK LIF (1) CEFAZOLIN RED LABEL (1) GENTAMICIN GREEN LABEL (1) AZUL DE METILENO LABEL (1) HEPARINE WHITE LABEL (1) LIDOCAINE YELLOW LABEL 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 900-1192, 10 lots: 113057752 113067947 113078458 113078680 113099381 140211710 140312054 140412584 140513072 140513334 |
|---|
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-2378-2014%22
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