DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Open Heart Pack A&B Pgybk, ref 89-7750.02 4) Open Heart Pack A&B Pgybk, ref 89-7750.03 5) Intl-Cardiac Surgery Pack A&B Pgybk, ref 89-8514.02 GEO-MED sterile custom surgical kits: 1) Open Heart Pack Pgybk, ref 89-5792.10 2) Open Heart A&B Pgybk, ref 89-7626.02 3) Open Heart A&B Pgybk, ref 89-7626.03 4) Open Heat Pack A&B Pgybk, ref 89-8440.01 5) Open Heart Pack A&B Pgybk, ref 89-8440.02
Class I - DangerousWhat Should You Do?
- Check if you have this product: Ref 89-7859.01: Lot numbers: 27369748, 27469087, 27964707, 28167081, 28207599, 28712544; Ref 89-7859.02: Lot numbers: 35947501, 35550352, 38844461 Ref 89-7750.02: Lot numbers: 29929171, 30474952 Ref 89-7750.03: Lot numbers: 30984021, 31210924 Ref 89-8514.02: Lot numbers: 37392319, 37078506, 37109721, 36974376, 37057289, 36813530, 37086725, 37099609, 37253124, 37325378, 37401318, 37413132 Ref 89-5792.10: Lot numbers: 39821181, 39507167, 39072116, 39863866 Ref 89-7626.02: Lot numbers: 36068496, 359097163, 35543822, 35328356, 35428242, 35549693, 34939471, 33091009, 34952712 Ref 89-7626.03: Lot numbers: 39301960, 36660692, 37008882, 37210095, 37915491, 37217991, 40101164, 37519742, 38455852, 38756495, 39417057, 39714051, 39913835 Ref 89-8440.01: Lot numbers: 36674648, 36612412 Ref 89-8440.02: Lot number: 36987476
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- DeRoyal Industries Inc
- Reason for Recall:
- These custom sterile surgical kits contain the component, ECOLAB ORS Fluid Warming and Slush Drape, which was recalled due to the possibility that the sterile packaging may contain small channels in the seal of the pouch.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Open Heart Pack A&B Pgybk, ref 89-7750.02 4) Open Heart Pack A&B Pgybk, ref 89-7750.03 5) Intl-Cardiac Surgery Pack A&B Pgybk, ref 89-8514.02 GEO-MED sterile custom surgical kits: 1) Open Heart Pack Pgybk, ref 89-5792.10 2) Open Heart A&B Pgybk, ref 89-7626.02 3) Open Heart A&B Pgybk, ref 89-7626.03 4) Open Heat Pack A&B Pgybk, ref 89-8440.01 5) Open Heart Pack A&B Pgybk, ref 89-8440.02
Product Codes/Lot Numbers:
Ref 89-7859.01: Lot numbers: 27369748, 27469087, 27964707, 28167081, 28207599, 28712544; Ref 89-7859.02: Lot numbers: 35947501, 35550352, 38844461 Ref 89-7750.02: Lot numbers: 29929171, 30474952 Ref 89-7750.03: Lot numbers: 30984021, 31210924 Ref 89-8514.02: Lot numbers: 37392319, 37078506, 37109721, 36974376, 37057289, 36813530, 37086725, 37099609, 37253124, 37325378, 37401318, 37413132 Ref 89-5792.10: Lot numbers: 39821181, 39507167, 39072116, 39863866 Ref 89-7626.02: Lot numbers: 36068496, 359097163, 35543822, 35328356, 35428242, 35549693, 34939471, 33091009, 34952712 Ref 89-7626.03: Lot numbers: 39301960, 36660692, 37008882, 37210095, 37915491, 37217991, 40101164, 37519742, 38455852, 38756495, 39417057, 39714051, 39913835 Ref 89-8440.01: Lot numbers: 36674648, 36612412 Ref 89-8440.02: Lot number: 36987476
Distribution:
Distributed in: MO, MA, NC, CT
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0363-2016
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