LAPAROSCOPY PACK- — Class I medical device recall Z-2327-2014
Terminated recall by Customed, Inc, reported 2014-09-10, distributed nationwide. Customed has determined that there is the possibility that packaging integrity may be compromised on different
| Recall number | Z-2327-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Customed, Inc, Fajardo, PR, United States |
| Recall initiated | 2014-05-20 |
| Classified | 2014-08-29 |
| Reported by FDA | 2014-09-10 |
| Terminated | 2017-08-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CR, DO, MX, TT |
| Reason classes | sterility, packaging |
| Lot numbers | 112030843, 112103944, 112114393, 112114480, 112125096, 113015452, 113036801, 113057847, 113078330, 113088867, 113089075, 113109844, 131110262, 131210818, 140111232, 140211671, 140412469, 140412888, 140513480 |
Product
LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9" X 96" LIF (5) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50" X 90" (4) DRAPE UTILITY WITH TAPE (3) DRAPE SHEET 41" X 58" SMS (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR (5) LAP SPONGE PREWASH 18" X 18" XRD (1) GOWN LGE SMS IMPERVIOUS REINFORCED (2) GOWN X-LARGE SMS IMPERV. REINFORCED (2) MEDICINE CUP 2oz. (1) NEEDLE HYPODERMIC 18G X 1% ST. ( 1) BLADE SURG. # 15 CARBON STEEL (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR (1) DRESSING TEGADERM 4" X 4%" (1) SOLUTION SURGICAL DURAPREP 6mL (1) TRAY MAYO SMALL (1) TUBE SUCTION CONNECT. %"X 12' (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) NEEDLE ECLIPSE 22 X 1% (1) TIME OUT BEACON NON WOVEN ST EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2327-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.