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Hemopore recallZ-1477-2025 · Stryker Corporation · initiated Feb 25, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

FDA root cause category: Under Investigation by firm

What the company is doing

An Urgent Medical Device Recall notification letter dated 2/24/25 was sent to customers. Actions to be taken 1. Immediately review your inventory to locate and quarantine any affected products at your facility. 2. Return the enclosed Business Reply Form (BRF), even if the affected product is no longer in inventory, to the email [email protected]. 3. Upon receipt of the completed BRF, Stryker will provide a shipping label to return recalled product on-hand. 4. A replacement will be provided upon receipt of the recalled product. 5. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. [email protected]. RESPONSE IS REQUIRED.

Recall details

Recall number
Z-1477-2025
Status
Open, Classified
Initiated by the company
Feb 25, 2025
Posted by the FDA
Mar 28, 2025
Recalling firm
Stryker Corporation
Quantity
182,344 total units
Product code
NHB
FDA submissions
K070715
Distribution
US Nationwide distribution.

Product description

Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

5400-020-208 UDI-DI: 07613327117233, Lot Numbers: 2022093020 2023011632 2023041321 2023062320 2023092220 2023112232 2024032120 2024052420 2022093021 2023011932 2023042120 2023062220 2023092932 2023112420 2024032820 2024052320 2022100720 2023012732 2023042121 2023073120 2023101220 2023112320 2024032920 2024060620 2022100620 2023013033 2023050320 2023073121 2023101221 2023120120 2024040520 2024060720 2022101320 2023020132 2023050220 2023081520 2023101921 2023113020 2024040420 2024062020 2022101420 2023020632 2023051620 2023081521 2023101920 2023120632 2024041820 2024062120 2022101720 2023022033 2023051720 2023082520 2023102721 2023121533 2024041920 2024070420 2022102120 2023030220 2023052620 2023082521 2023102720 2024010532 2024042632 2024070520 2022102720 2023030320 2023052520 2023083120 2023110320 2024020120 2024042520 2024071538 2022102820 2023032420 2023060120 2023090120 2023110220 2024020220 2024042620 2024071738 2022110220 2023032320 2023060220 2023090820 2023110733 2024030820 2024050821 2022110320 2023032920 2023060820 2023090620 2023110920 2024030720 2024050820 2022112932 2023033020 2023060920 2023091520 2023110921 2024031420 2024051520 2023010433 2023040732 2023061520 2023091420 2023111720 2024031520 2024051721 2023010932 2023041320 2023061620 2023092120 2023111620 2024032220 2024052332 7; 5400-020-208ITL UDI-DI: 07613327602623, Lot Numbers: 2024052333

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 96393).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page