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U.S. Department of Health and Human Services

Class 2 Device Recall Kendall SCD Express Sterile Sleeves (Thigh Length)

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 Class 2 Device Recall Kendall SCD Express Sterile Sleeves (Thigh Length)see related information
Date Initiated by FirmFebruary 15, 2019
Create DateMarch 22, 2019
Recall Status1 Terminated 3 on July 24, 2020
Recall NumberZ-1041-2019
Recall Event ID 82245
510(K)NumberK781357 
Product Classification Sleeve, limb, compressible - Product Code JOW
ProductKendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
Code Information Lot Number 83410S09D
Recalling Firm/
Manufacturer		 COVIDIEN LLC
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact
800-292-9332
Manufacturer Reason
for Recall		The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.
FDA Determined
Cause 2		Under Investigation by firm
ActionUrgent Medical Device Recall notification letters dated 2/15/19 were sent to customers. An additional customer was identified and a letter was sent on 3/11/19.
Quantity in Commerce25 units
DistributionThe products were distributed to the following US states: CA, NJ, and WA.
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.
510(K) Database510(K)s with Product Code = JOW
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