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.

ANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) TABLE 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

ANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) TABLE COVER REINFORCED 50" x 90" LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F (2) CUP MEDICINE 2oz LIF (2) UTILITY BOWL 32oz LIF (1) EMESIS BASIN 101N 700cc (4) TOWEL CLAMP (3) TOWELS ABSORBENT 15" x 20" LIF (1) MOSQUITO HALSTED (2) CHLORASCRUB SWABSTICK 5.1ML (1) PLATFORM TRAY LARGE (1) SCALPEL SAFETY #11 (3) LABELS FOR SKIN MARKER (1) LABEL F/MED. SALINE NORMAL BLUE (1) NEEDLE HYPODERMIC 18G X 1 Y2 (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 16oz (4) BAND BAG WITH RUBBAND & TAPE LIF (20) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) FEMORAL ANGIOGRAPHY DRAPE WITH POUCH (1) NEEDLE HYPODERMIC 21G X 1 Y2 (1) GOWN STANDARD SMS LARGE (2) NEEDLE HYPODERMIC 23GA X 1" (1) GOWN SMS LARGE NON REINFORCED TOWEL/WRAP (1) LABEL FOR MEDICATION TRIDIL VIOLETA (1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) LABEL CONTRASTE FOR MEDICATION GREEN (1) WASH BASIN ROUND 6QT. Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Quantity: 21 lots/ 1196 units, multiple units per lot

Why Was This Recalled?

Customed has determined that there is the possibility that packaging integrity may be compromised on differ 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