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Device Recall DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution
Model / Serial
REF 89-5720.04, Lot Number 38322988; REF 89-6717.03, Lot Numbers: 38323059 and 38342436
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
SC, FL, OH, NJ, OK, MN, AR
Product Description
DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF, or 2016-09EG, or Catalog No. 863, Lot No. 2016-08DC: || TOTAL JOINT PACK A&B;, REF 89-5720.04; PACEMAKER PACK, REF 89-6717.03
Manufacturer
DeRoyal Industries Inc
1 Event
Recall of Device Recall DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution
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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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