FDA Device recall Z-2512-2014
TLIF PACK SURGICAL CENTER, CODE 900-2918
- FDA Device
- Class I
- terminated
- Published 2014-09-10
On 2014-09-10 the FDA classified a Class I recall of TLIF PACK SURGICAL CENTER, CODE 900-2918 by Customed, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2512-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-05-20 |
| Published | 2014-09-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Customed |
| Distribution | US |
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
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.
Identifiers
| code_info | Code 900-2918, 8 lots 113047023 113057703 113068037 113078429 113078733 113109799 140312147 140613795 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2512-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.