TLIF PACK SURGICAL CENTER — Class I medical device recall Z-2512-2014
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-2512-2014 |
|---|---|
| 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 | 113047023, 113057703, 113068037, 113078429, 113078733, 113109799, 140312147, 140613795 |
Product
TLIF PACK SURGICAL CENTER, CODE 900-2918. CONTENTS: (2) SOLUTION SURGICAL DURAPREP 26ML UF (6) Pr. GLOVE SURG. DERMA PRENE # 8 PF UF (4) GOWN SOFT SMS STD XL SET IN SLEEVE UF (4) TOWELS ABSORBEN 15" X 20" LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE% 60" X 76" REINFORCED L/F (1) DRAPE CHEST 100" X 142" X 72" LIF (1) FLUORO COVER 30" X 30" WITH RUBBBAND LIF (2) LITE GLOVE LIF (2) TUBE SUCTION CONNECT. Y." X 12' UF (12) TOWELS CLOTH HUCK BLUE LIF (1) UTILITY BOWL QUART 32oz (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) CAUTERY PENCIL ROCKER SWITCH WITH HOLSTER LIF (1) STERI STRIP DRAPE LARGE 17" X 23" LIF (1) SKIN MARKER WITH RULER UF (9) LABELS FOR SKIN MARKERS 1.25 X Y2 (1) RULER (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG L/F (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) BULB SYRINGE 60cc LIF (4) NEEDLE HYPODERMIC 18G X 1Y2 UF (1) NEEDLE HYPODERMIC 22G X 1Y2 LIF (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK UF (1) NEEDLE SPINAL 18G X 6" LONG LENGTH LIF (1) BLADE SURGICAL # 10 CARBON STEEL (1) BLADE SURGICAL # 15 CARBON STEEL (1) TIME OUT BEACON NON WOVEN UF (2) DRESSING TEGADERM 4" X 4% "UF (2) MEDICINE CUP 2oz (1) DRAPE IOBAN INCISE 2 ANTIMICROBIAL 23" X 23" LIF 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-2512-2014. 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.