Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

NEURO SPINE PACK Recalled by Customed, Inc Due to Customed has determined that there is the possibility...

Date: May 20, 2014
Company: Customed, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Customed, Inc directly.

Affected Products

NEURO SPINE PACK , CODE 900-2765 CONTENTS: (l ) DRAPE INCISION 23" X 1 7" (I) SCALPEL W/HANDLE # 15 S/STEEL (I) INSTRUMENT POUCH 7 X 1 1 2 COMPART (I) Pk. STRIP SURGICAL W' X 6" (I) CAUTERY PENCIL HAND SWITCHING LIF (4) UTILITY DRAPE W/TAPE L/F (I) SCALPEL W/HANDLE # 10 S/STEEL (I) TUBE SUCTION CONNECT W' X I 2' LIF (I) SKIN MARKER W/RULER (2) SPECIMEN CONTAINER4oz W/LID & LABEL (I) SOLUTION SURGICAL DURAPREP 26ML LIF (I) YANKAUER SUCTION TUBE W/0 VENT LIF (I) MAYO TRAY LARGE (2) NEEDLE & BLADE COUNTER lOc MAG/CLEAR (I) DRAPE INCISE ANTIMICROBIAL 23" X 1 7" LIF (2) SYRINGE I Occ W/0 NEEDLE LUER LOCK LIF (I) J VAC RESERVOIR 300ML (2) LITE GLOVE LIF (2) CAUTERY TIP POLISHER LIF (2) TABLE COVER BTC 77" X 110" HD FULL L/F (20) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (4) TOWELS ABSORBENT 1 5" X 20" LIF ( I ) DRAPE T LAPAROTOMY 102" X 78" X 1 21" STD SMS (5) LAP SPONGE PREWASH 18" X 18" XRD LIF ( I) SUTURE BAG FLORAL (5) DRAPE 'l'4 ECONOMY 53" X 77" LIF (3) GOWN IMPERVIOUS EXTRA REI NF. LGE T/WRAP (I) UTILITY BOWL 1 6oz LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Quantity: 6 lots,132 units (multiple units per package)

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Customed, Inc

Customed, Inc has 682 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report