GENERAL MINOR PACK- — Class I medical device recall Z-2351-2014
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-2351-2014 |
|---|---|
| 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 | 109010128, 112030747, 112052015, 112062577, 112093733, 112114397, 112114483, 112125114, 113015516, 113025969, 113036383, 113047206, 113057819, 113068181, 113078606, 113099296, 113099577, 131110278, 131110606, 131210973, 140111454, 140211879, 140312331, 140412842, 140513251 |
Product
GENERAL MINOR PACK- (1) MAYO STAND COVER REINFORCED LIF (2) BOWL UTILITY 16oz LIF (1) TIP CAUTERY POLISHER LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) BOWL UTILITY 32oz (1) BAG SUTURE FLORAL (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (10) GAUZE SPONGES 4" X 4" 16PLY XRD LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS LIF (1) CAUTERY PENCIL ROCKER SWITCH LIF (1) BLADE SURGICAL #10 STAINLESS STEEL (1) TUBE SUCTION CO NNECTING ~" X 12' LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (2) LITE GLOVES LIF (1) DRAPE LAPAROTOMY WITH POUCH 102" X 121" X 78" STD SMS (4) DRAPE UTILITY WITH TAPE LIF (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) BLADE SURGICAL #15 CARBON STEEL (2) SHEET DRAPE 41" X 69" MEDIUM LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF 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-2351-2014. 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.