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Devices
Various DeRoyal Surgical Kits
Model / Serial
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
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in MO, MA, NC, CT, Kuwait.
Product 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
Manufacturer
DeRoyal Industries Inc
1 Event
Recall of Various DeRoyal Surgical Kits
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Manufacturer
DeRoyal Industries Inc
Manufacturer Address
DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
Manufacturer Parent Company (2017)
Deroyal Industries Inc.
Source
USFDA
Language
English
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