CYSTO TUR PACK- — Class I medical device recall Z-2325-2014
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-2325-2014 |
|---|---|
| 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 | 110020453, 110030667, 110051146, 111030671, 111040897, 111061672, 111071814, 111082217, 111092389, 111102877, 111113116, 111123253, 112010174, 112030874, 112041411, 112072872, 112083431, 113015513, 113015697, 113036365, 113047211, 113057626, 113078328, 113088864, 113109841, 131110304, 140111229, 140312164, 140412467 |
Product
CYSTO TUR PACK- - (1) UTILITY BOWL 32oz LIF (1) SPECIMEN CUP WITH CAP 4oz LIF (1 0) GAUZE SPONGE 4" X 4" 12PL Y LIF (4) ABSORBENT TOWELS 15" X 20" LIF (1) CYSTOSCOPY 'T' DRAPE 60" X 87" X 35" SMS STD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (2) LEGGINS WITH 7" CUFF 30" X 42" LIF (1) TABLE COVER REINFORCED 44" X 78" LIF (1) UNDERBUTTOCK DRAPE WITH POUCH 44" X 35" LIF (1) SYRINGE 60ML SLUER SLIP WITHOUT NEEDLE LIF (1) TUR Y SET 81 "2.1 M REGULAR CLAM (4) GAUZE SPONGES 4" X 4" 12 PLY XRD L/F 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-2325-2014. 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.