Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Breast pack TPSC Recalled by Customed, Inc Due to Customed has determined that there is the possibility...
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
Breast pack TPSC, code 900-3431, contains: (1) GOWN LARGE STANDARD SMS AAMIIII (1) GOWN SOFT SMS STD. X-LARGE AAMIIII (4) TOWELS ABSORBENT 15" X 20" LIF (1) PENCIL CAUTERY PUSH BOTTOM LIF (1) SYRINGE 60ML LUER LOCK WITHOUT NEEDLE L/F (1) TUBE SUCTION CONNECT X" X 12' LIF (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG L/F (1) COVER MAYO STAND REINFORCED LIF (2) SKIN MARKER INK WITH 8 LABEL/TIME OUT RULER LIF (2) BOWL UTILITY QUART 32oz. (1) COVER TABLE REINFORCED 50" X 90" LIF (1) RULER LIF (4) DRAPE UTILITY LIF (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) DRAPE BREAST/CHEST SMS LIF (1) GAUZE KERLIX 4.5"X 4 1/8 YD 6PL Y L/F (2) LITE GLOVES (5) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) SHEET DRAPE 42" X 57" SMS LIF (1) SHEET DRAPE 70" x 100" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Quantity: 1 lot/ 45 units
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.
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