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Class 2 Device Recall White OR Towels |
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Date Initiated by Firm |
April 19, 2017 |
Create Date |
May 17, 2017 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2101-2017 |
Recall Event ID |
77063 |
Product Classification |
Gauze/sponge, internal, x-ray detectable - Product Code GDY
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Product |
White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs.
Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases. |
Code Information |
Material Number: MSPT524, Lot #229445, Exp. Date: 10/12/2021. |
Recalling Firm/ Manufacturer |
Medical Action Industries Inc 25 Heywood Rd Arden NC 28704-9302
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For Additional Information Contact |
Nichole K Early 828-681-8820 Ext. 258
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Manufacturer Reason for Recall |
Lint present on sterile Operating Room Towels.
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FDA Determined Cause 2 |
Other |
Action |
Consignees were notified via Medical Device Notification of Recall notice on/about 4/19/2017. |
Quantity in Commerce |
69 cases |
Distribution |
AR, IN and NV. |
Total Product Life Cycle |
TPLC Device Report
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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