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U.S. Department of Health and Human Services

Class 2 Device Recall Homopore

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 Class 2 Device Recall Homoporesee related information
Date Initiated by FirmFebruary 25, 2025
Date PostedMarch 28, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1482-2025
Recall Event ID 96393
510(K)NumberK070715 
Product Classification Polymer, ear, nose and throat, synthetic, absorbable - Product Code NHB
ProductHemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
Code Information 5400-222-208S UDI-DI: 07613327500486, Lot Numbers: 2024020221 2024051720 2024082321
Recalling Firm/
Manufacturer		 Stryker Corporation
1941 Stryker Way
Portage MI 49002-9711
For Additional Information ContactBrooke Thompson
269-290-0524
Manufacturer Reason
for Recall		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 Determined
Cause 2		Under Investigation by firm
ActionAn 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 Instruments.Recalls@stryker.com. 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. Instruments.recalls@stryker.com. RESPONSE IS REQUIRED.
Quantity in Commerce182,344 total units
DistributionUS Nationwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NHB
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