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U.S. Department of Health and Human Services

Class 2 Device Recall suction canister kit

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 Class 2 Device Recall suction canister kitsee related information
Date Initiated by FirmAugust 22, 2014
Date PostedOctober 20, 2014
Recall Status1 Terminated 3 on April 15, 2015
Recall NumberZ-0098-2015
Recall Event ID 69319
Product Classification Bottle, collection, vacuum - Product Code KDQ
ProductDeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital
Code Information Lot 364817213
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information ContactMr. Tracy Edmundson
865-362-2334
Manufacturer Reason
for Recall		These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.
FDA Determined
Cause 2		Process control
ActionDeRoyal sent an Urgent Voluntary Recall letter dated August 22, 2014, to all affected consignees by overnight letter or by email. DeRoyal was to follow up with non-responding accounts before October 1, 2014. Customers were instructed to check their inventory for the affected product. If they have affected product, customers were instructed to destory both the liner and the lid and dispose of it according to their facility's procedures. Customers were instructed to return the included Notice of Destruction to recalls@deroyal.com even if they no longer have affected product. Customers with questions were instructed to contact their DeRoyal Sales Representative or DeRoyal Customer Service at 1-800-251-9864. For questions regarding this recall call 865-362-2334.
Quantity in Commerce5112 units
DistributionNationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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