ORTHOPEDIC PACK BASIC CODE 900-2830 — Class I medical device recall Z-2507-2014
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-2507-2014 |
|---|---|
| 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 | 140111332, 140211832, 140412672 |
Product
ORTHOPEDIC PACK BASIC CODE 900-2830. CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21 SPLIT (1) DRAPE% ECONOMY 53" X 77" (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) SHEET SPLITW/ADHES 108" X 77" STD SMS (1) COVER TABLE REINFORCED 50" X 90" (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) TIME OUT BEACON NON WOVEN (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill (1) POLISHER CAUTERY TIP (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) COUNTER NDLIBLADE 20C FOAM/MAG (1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER (1) GOWN IMPERVIOUS EXTRA REINFORCED LGE T/WRAP AAMI LEVEL Il (1) BAG GLASSINE PLAIN (1) ELECTRODE DUAL DEPRES 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-2507-2014. 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.