EXTREMITY ARM PACK CONTENTS: — Class I medical device recall Z-2456-2014
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-2456-2014 |
|---|---|
| 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 | 140211465, 140211702, 140412558, 140512912 |
Product
EXTREMITY ARM PACK CONTENTS: (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) GOBAN SELF-ADHERENT WRAP 6" X 5yds (3) BANDAGE ELASTIC 4" X 5yds (1) BANDAGE ESMARK 6" X 9 (1) UTILITY BOWL QUART 32oz (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECTX 12' (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (3) SCALPEL WITH HANDLE# 15 STAINLESS STEEL (1) TIME OUT BEACON NON WOVEN (1) LIGHT SHIELD (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" (2) NEEDLE & BLADE COUNTER 10c MAG/CLEAR (1) U-DRAPE 60"X 70" WITH TAPE SPLIT 6" X 21" (1) NEEDLE SPINAL ANESTH 18G X 3% (3) GOWN X-LARGE IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (4) DR APE UTILITY WITH TAPE (6) TOWEL ABSORBENT 15" X 20" (3) DRAPE % ECONOMY 53" X 77" (1) YANKAUER OPEN TIP CLEAR W/0 CN (1) CAUTERY TIP POLISHER (1) SUTURE BAG FLORAL (1) GOWN SURG REINFORCED X-LARGE TOWEL & WRAP (1) MERLING SKIN PREP APPLICATOR 39ML (1) SHEET HAND 146" X 104" X 91" (1) TABLE COVER REINFORCED 50" X 90" Product Usage: 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-2456-2014. 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.