Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
Summary
The FDA issued a Class II for Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 1 by Aspen Surgical Products, Inc.. Reason: Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process wa.
Details
Source
Device Recall
External ID
Z-2388-2021
Action Date
2021-09-08
Status
Terminated
Category
device
Product Description
Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
Lot/Code Info: All lots manufactured between July 9, 2019 to July 9, 2021
Quantity Affected: 1429
Reason for Recall
Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.
Distribution
US nationwide distribution. No foreign distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-23
Company
Caledonia, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 126 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Aspen Surgical Products, Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aspen Surgical Products, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aspen Surgical Products, Inc. have FDA actions?
Aspen Surgical Products, Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2388-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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