Z-2224-2021Class II

CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge...

Name: Z-2224-2021 CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge...
Creator: Integra LifeSciences Corp.
Published: 2021-06-01
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2021-06-01 / Terminated / root cause: packaging

FDA source

Integra LifeSciences Corp. began a recall of CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037 on 2021-06-01. FDA classified it as Class II and gives the reason as "Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2224-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-01
Posted: 2021-08-06
Terminated: 2023-01-27
Recalling firm: Integra LifeSciences Corporation
Product: CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037
Product code: HBO Clip, Scalp
Reason for recall: Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier
Root cause tag: packaging
FDA root cause: Process change control
Action: Integra notified consignees (Hospitals, Government facilities, and Distributors) by letter via FedX 2 Day Mail on June 1, 2021 and email to Distributor. Letter states reason for recall, health risk and action to take: We request that you take the following actions: 1. Customers a. If you do have units of the affected product listed in Table 1, remove it immediately from service. b. If you do have affected product, check the box on the enclosed form I do have affected product. Record the total quantity of the affected product that you have. c. If you do not have affected product, check the box, I do not have affected product. d. Complete the attached Acknowledgement Form and return to [email protected] or FAX to 1-609-750-4220. e. Keep a copy of the form for your records. f. When your form is received, and it is noted that you have affected product, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the affected product. A replacement order will also be placed for the quantity noted on the form. 2. Distributors a. If you do have the affected product listed in Table 1, remove the product from further distribution. b. Complete the attached form. If you do not have affected product, check the box, I do not have affected product. c. If you do have affected product, check the box I do have affected product. Record the total quantity of affected product you have. d. Complete the attached Acknowledgement Form and return to [email protected] or FAX to 1-609-750-4220. e. Keep a copy of the form for your records. f. Please check your customer traceability records for shipments of above catalog numbers. g. Forward a copy of the enclosed Field Safety Notice to any of your customers that have purchased the above catalog and lot number. h. When the form from you and your customer is received, and it is noted that you or your customer has affected product, Customer Service will co
Quantity in commerce: 906 units
Distribution: US Nationwide Distribution - Foreign Distribution: Hong Kong
Product codes and lots: Lot Numbers: W2102045, W2102046, W2102048 and W2102049 GTIN# 10381780511625

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2224-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2224-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-06

Product code HBO

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)