CLASS II Device recall · Reported 14 Mar 2018 · FDA Enforcement Report
241-McKesson Premium Skin Staple Remover Kit recalled
Cypress Medical Products is recalling 241-McKesson Premium Skin Staple Remover Kit, distributed in 13 states. The recall was initiated on 17 Nov 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0932-2018
- FDA event ID
- 79341
- Recalling firm
- Cypress Medical Products, Richmond, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Nov 2017
- FDA classified
- 8 Mar 2018
- Reported
- 14 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Surgical Instruments
Timeline
| 17 Nov 2017 | Recall initiated by company | |
| 8 Mar 2018 | Classified by FDA | +111 days |
| 14 Mar 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product not meeting the iodine assay level requirements to support 36 month expiration dating.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to states of: CO, FL, GA, KY, MI, MO, NC, NH, OH, TN, TX, WA, AND WI.
ColoradoFloridaGeorgiaKentuckyMichiganMissouriNorth CarolinaNew HampshireOhioTennesseeTexasWashingtonWisconsin
Questions about this recall
Why was it recalled?
Product not meeting the iodine assay level requirements to support 36 month expiration dating.
Which lots are affected?
Item 241, 100123, 100124, 82-15
Where was it sold?
US Distribution to states of: CO, FL, GA, KY, MI, MO, NC, NH, OH, TN, TX, WA, AND WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cypress Medical Products
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | General Purpose Syringe McKesson Luer Lock Tip Without Safety recalled | Cypress Medical Products | Other | Nationwide |
| Device | CLASS II | Acceava Respiratory Strep A, CLIA Waived recalled | Cypress Medical Products | Other | Nationwide |
| Device | CLASS II | BinaxNOW Respiratory Strep A Test Kit, CLIA Waived recalled | Cypress Medical Products | Other | Nationwide |
| Device | CLASS II | McKesson Syringe 60CC, Luer Lock Tip, Sterile recalled | Cypress Medical Products | Other | Nationwide |
| Device | CLASS II | McKesson Lap Sponge, X-Ray Detectable 12"x 12" recalled | Cypress Medical Products | Sterility | VA |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |