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U.S. Department of Health and Human Services

Class 2 Device Recall Reprocessed Kendall Impad Rigid Sole Foot Cover

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  Class 2 Device Recall Reprocessed Kendall Impad Rigid Sole Foot Cover see related information
Date Initiated by Firm April 14, 2023
Date Posted May 19, 2023
Recall Status1 Open3, Classified
Recall Number Z-1612-2023
Recall Event ID 92138
510(K)Number K100909  
Product Classification Sleeve, limb, compressible - Product Code JOW
Product REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
Code Information Lot # 0000157564, UDI-DI: 00885825013585
Recalling Firm/
Manufacturer		 Stryker Sustainability Solutions
1810 W Drake Dr
Tempe AZ 85283-4327
For Additional Information Contact SSS Sales Representative
888-888-3433
Manufacturer Reason
for Recall		 Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.
FDA Determined
Cause 2		 Under Investigation by firm
Action On April 14, 2023, Stryker Sustainability Solutions (SSS) issued an "urgent Medical Device Recall" notification via E-Mail. SSS asked consignees to take the following action: 1) Please check your inventory for the devices from the affected lot and remove them from their point of use. Refer to Figure 1 Product Label. 2) Please complete the Urgent Medical Device Recall Business Reply Form (page 3) and indicate if any of the affected product remains in your inventory. Please return this completed form through one of the following methods: a. Email: SSSPFA@stryker.com b. To your Stryker s Sustainability Solutions Sales Representative c. Fax: 480-763-5345 This form must be completed and returned to Stryker even if no affected product is found. 3) Maintain awareness of this communication internally until all required actions have been completed within your facility. 4) If any of the affected products have been forwarded to additional facilities (including but not limited to distribution warehouses), please contact these facilities and communicate this recall to them. Please instruct these facilities to complete the Business Reply Form (page 3) and return the completed form either via email to SSSPFA@stryker.com, to their Stryker s Sustainability Solutions sales representative, or via fax to 480-763-5345. Alternatively, provide contact details so Stryker can inform the recipients appropriately. 5) If the form indicates that any affected product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for all devices that are returned.
Quantity in Commerce 50 units
Distribution US: WA OUS: None
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.
510(K) Database 510(K)s with Product Code = JOW and Original Applicant = ASCENT HEALTHCARE SOLUTIONS
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