Z-0932-2018Class II

241-McKesson Premium Skin Staple Remover Kit, Item #100123, McKesson I.V. Start Kit, 100124-McKesson Suture...

Name: Z-0932-2018 241-McKesson Premium Skin Staple Remover Kit, Item #100123, McKesson I.V. Start Kit, 100124-McKesson Suture...
Creator: Cypress Medical Products LLC
Published: 2017-11-17
License: https://open.fda.gov/license/

Cypress Medical Products LLC / initiated 2017-11-17 / Terminated / root cause: manufacturing process

FDA source

Cypress Medical Products LLC began a recall of 241-McKesson Premium Skin Staple Remover Kit, Item #100123, McKesson I.V. Start Kit, 100124-McKesson Suture Removal Kit, and 82-15 Cypress Medical Products... on 2017-11-17. FDA classified it as Class II and gives the reason as "Product not meeting the iodine assay level requirements to support 36 month expiration dating". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0932-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-17
Posted: 2018-03-08
Terminated: 2020-04-08
Recalling firm: Cypress Medical Products LLC
Product: 241-McKesson Premium Skin Staple Remover Kit, Item #100123, McKesson I.V. Start Kit, 100124-McKesson Suture Removal Kit, and 82-15 Cypress Medical Products Skin Staple Remover Kit. McKesson Item # 241, 100123, and 100124, Cypress Item # 82-15 Manual surgical instrument for general use.
Product code: N/A
Reason for recall: Product not meeting the iodine assay level requirements to support 36 month expiration dating.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Cypress Medical Products, sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" letter dated 11/16/2017 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to immediately discontinue use of any product matching the affect items; If you have product affected by this notice, a recall label must be applied to each affected convenience kit. Please contact Cypress Medical Products, LLC customer service via email at [email protected] to request the number of labels required. Upon opening the kit during procedure time, please dispose of the affected Aplicare Povidone Iodine Prep Pad in accordance with your institutions policies and procedures. If you have further distributed the product, please notify your customers and provide the customer with a copy of this notification. Complete and return the Reply form via email to: Cypress Medical Products LLC, Attn: Cypress Customer Service at: [email protected], even if you have no affected product. To ensure product availability, new orders for the affected convenience kits will be shipped with the affixed recall labels until new product is made available from the manufacturer. If you have any questions concerning this recall, please contact Cypress Customer Service at the email: [email protected].
Quantity in commerce: 12,206 cases
Distribution: US Distribution to states of: CO, FL, GA, KY, MI, MO, NC, NH, OH, TN, TX, WA, AND WI.
Product codes and lots: Item 241, 100123, 100124, 82-15

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0932-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0932-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-08

Product code N/A

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)