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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal (R) Surgical Eye Spears

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 Class 2 Device Recall DeRoyal (R) Surgical Eye Spearssee related information
Date Initiated by FirmAugust 12, 2013
Date PostedNovember 14, 2013
Recall Status1 Terminated 3 on August 04, 2014
Recall NumberZ-0275-2014
Recall Event ID 66608
Product Classification Sponge, ophthalmic - Product Code HOZ
ProductDeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning of fluids from surgical site in or near the eye
Code Information Lot Number 32794811
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		One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.
FDA Determined
Cause 2		Employee error
ActionDeRoyal Industries sent an Urgent Voluntary Recall letter dated August 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease usage and return the product to: DeRoyal Recalls RA#: Eye Spears 1755 Hwy 33 South New Tazewell, TN 37825 Ship via UPS Ground using Shipper #312780 Distributors were requested to notify their consignees of the same. The recall is extended to the user level. Customers with questions were instructed to call 1-800-251-9864. For questions regarding this recall call 865-362-2334.
Quantity in Commerce726 cases (7242 units)
DistributionNationwide Distribution
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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