ARTHROSCOPY PACK — Class I medical device recall Z-2344-2014
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-2344-2014 |
|---|---|
| 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 | 112030744, 112041351, 112052010, 112062505, 112072876, 112093641, 112104101, 112114588, 112125111, 113015457, 113025967, 113036380, 113057877, 113088887, 113099452, 113099576, 131110272, 131210839, 140111248, 140211735 |
Product
ARTHROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) STOCKINETTE IMPERVIOUS 14" X 48" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) BLADE SURGICAL # 11 STAINLESS STEEL (1) NEEDLE HYPODERMIC 21G X 1 ~ LIF (1) TUR Y SET 81" 2.1M REGULAR CLAM (1) NEEDLE HYPODERMIC 18G X 1 ~ (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y (1) SHEET DRAPE 70" X 100" LIF (1) *Pr. SURGEON NEUTRALON GLOVE #8 LATEX (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1 ) TUBE SUCTION CONNECT. X" X 12' LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" (1 ) DURAPREP SURGICAL SOLUTION 26ML LIF (1 ) NEEDLE SPINAL ANEST. 18G X 3 %" LIF (2) ELASTIC BANDAGE 6" X 5YRD. LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) PAD ABDOMINAL 8" X 7.5" (1) *Pr. SURGEON NEUTRALON GLOVE #8 ~ LATEX 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-2344-2014. 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.