Z-1228-2022Class II

(1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped...

Name: Z-1228-2022 (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped...
Creator: BSN Medical Inc
Published: 2022-02-01
License: https://open.fda.gov/license/

BSN Medical / initiated 2022-02-01 / Terminated / root cause: labeling and UDI

FDA source

BSN Medical Inc began a recall of (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of... on 2022-02-01. FDA classified it as Class II and gives the reason as "The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1228-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-01
Posted: 2022-06-03
Terminated: 2023-08-09
Recalling firm: BSN Medical
Product: (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.
Product code: FQM Bandage, Elastic
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The recalling firm issued letters dated 1/31/2022 on 2/1/2022 via email and made telephone calls. The letter informed the consignee of the issue, provided photographs of the labeling, and requested the consignee check their inventory to determine if they have the affected lot number of JOBST Compri2 and JOBST Compri2 Lite in their inventory. If they do, they are requested to quarantine the product and share this information with additional departments as needed. Enclosed with the letter was a Response Form for completion, as well as prepared labels for return of the affected product. The response form and the affected product were to be returned to the firm. The letter also informs the consignee to ensure all users and individuals in their organization be informed of the recall. If the consignee supplies products to third parties, they are requested to forward a copy of the information or inform the recalling firm's contact person. Based on feedback from the Division on their recall letter, the letter was updated to extend the recall to all direct account locations. The updated letters dated 2/3/2022 were issued beginning 2/4/2022 via email and phone calls were again made. The letters were similar to the previous letter dated 1/31/2022 except there was an instruction added that said if the product was further distributed to customers of the consignee, they are to provide a list of those customers to BSN Medical so that BSN can follow-up with them regarding the recall. In the event the consignee does not want to provide a copy of their customer list, they are requested to supply data to support their firm's compliance with the customer recall notification.
Quantity in commerce: 1,677
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1228-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1228-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-15	2022-06-03

Product code FQM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)