(1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compressio
Summary
The FDA issued a Class II for (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped pa by BSN Medical Inc. Reason: The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled..
Details
Source
Device Recall
External ID
Z-1228-2022
Action Date
2022-06-15
Status
Terminated
Category
device
Product Description
(1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of approximately 40 mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes. (2) JOBST Compri2 lite, REF 76271-02, containing 2 components, one plastic-wrapped padding (as is contained in REF 76271-01) and one plastic wrapped compression bandage with a compression of approximately 20-30mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes.
Lot/Code Info: Lot #127384, Exp. 2024-02-10 UDI for JOBST Compri2 - (01)04042809506648(20)01(17)240210(10)127384; UDI for JOBST Compri2 lite - (01)04042809506631
Quantity Affected: 1,677
Reason for Recall
The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled.
Distribution
US Nationwide distribution in the states of AZ, FL, CA, IL, KS, MA, MN, MO, NC, NH, OH, PA, TX, VA, and WA. There was no foreign/government/military distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-01
Company
Charlotte, NC
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 178 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (BSN Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BSN Medical Inc have FDA actions?
This is the only FDA action we have on record for BSN Medical Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1228-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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