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U.S. Department of Health and Human Services

Class 2 Device Recall Laparotomy Sponge

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 Class 2 Device Recall Laparotomy Spongesee related information
Date Initiated by FirmNovember 27, 2018
Create DateDecember 22, 2018
Recall Status1 Terminated 3 on February 08, 2019
Recall NumberZ-0681-2019
Recall Event ID 81640
Product Classification Gauze/sponge, internal, x-ray detectable - Product Code GDY
ProductLaparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for application to internal organs or structure to control bleeding, absorb fluid, or protect organs or structures from abrasions, drying, or contamination.
Code Information Model Number: 403, Lot Number: 1806JK305A, Expiration Date: 06/20/2023, UDI (Pack): 10809160000113, UDI (Case): 50809160000111
Recalling Firm/
Manufacturer		 Medical Action Industries Inc
25 Heywood Rd
Arden NC 28704-9302
For Additional Information ContactNichole Early
828-338-7568
Manufacturer Reason
for Recall		Potential compromise of product sterility due to breach of sterile barrier.
FDA Determined
Cause 2		Under Investigation by firm
ActionMedical Action Industries notified customers on about 11/27/2018 via "URGENT MEDICAL DEVICE NOTICE OF RECALL" Letter. Consignees were instructed to immediately examine inventory, quarantine all affected product, notify customers if the affected product was further distributed, and complete and return the recall response form. For consignees with affected product in inventory, Medical Action Industries will issue a Returned Materials Authorization (RMA) to return affected product.
Quantity in Commerce13 cases (2,600 sponges)
DistributionDevices were distributed in 5 U.S states: MN, WA, NY, MA and MI. No product was distributed outside of the US.
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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