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U.S. Department of Health and Human Services

Class 2 Device Recall Quick Release Gait Belt, 60

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  Class 2 Device Recall Quick Release Gait Belt, 60 see related information
Date Initiated by Firm September 15, 2020
Create Date October 05, 2020
Recall Status1 Open3, Classified
Recall Number Z-0055-2021
Recall Event ID 86448
Product Classification Aid, transfer - Product Code IKX
Product Quick Release Gait Belt, 60
Code Information Model: MDT821208NATM /503689 Lots: 33019040001, 33019090001 and 33019100001  Used in kits with model number: DYKF1045 Lots: 20EBB832 and 20EBM643. 
Recalling Firm/
Manufacturer		 Medline Industries Inc
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Kassandra Cotner
866-359-1704
Manufacturer Reason
for Recall		 The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.
FDA Determined
Cause 2		 Process design
Action On Sep 15 2020 the firm sent an notification to its customers via email, with the following instructions: REQUIRED ACTION: 1. Immediately check your stock for the specific kit number and the affected kit lot number in the attached list. Quarantine any kits with the listed lot numbers. If you dont have any of the lots listed above skip to step 3. 2. Remove affected Gait Belts prior to use of the Fall Prevention Kit. Please be sure NOT to use the recalled Gait Belts and return those to Medline. Medline will supply replacement belts at no charge to you. 3. Please return the completed enclosed verification form listing the quantity of affected product on hand. Even if you do not have any affected product please complete and return the form, via email as indicated on the verification form. 4. Return the enclosed Verification Form via email to recalls@medline.com or fax 866-767-1290. 5. If you are a distributor, promptly notify any of your customers that may have received affected product. Note: By signing and returning the Verification Form, you acknowledge that you received and understand this notification.
Quantity in Commerce 13,500 units
Distribution Domestic Distribution Only: IL, MI
Total Product Life Cycle TPLC 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 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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