Richmond, VA, United States
Cypress Medical Products LLC recalls
8 recalls recorded since 2018, most recently on 20 August 2024. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)3
Terminated or completed5
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 August 2024
- Reason
- Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3184-2024, Z-3185-2024
- BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
- Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
Ongoing Class II Medical devices
- Recall started
- 6 August 2024
- Reason
- The syringes that were inadvertently shipped from the Distribution Center. This product was on quarantine because FDA has stated that these syringes lack FDA clearance and were inadvertently shipped due to an internal order processing error.
- Distribution
- US Nationwide distribution in the states of CA, NV, NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3154-2024
- General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C
Ongoing Class II Medical devices
- Recall started
- 24 July 2024
- Reason
- Affected syringes lack FDA clearance.
- Distribution
- US distribution only. Domestic distribution nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2940-2024
- McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS)
Terminated Class II Medical devices
- Recall started
- 11 August 2021
- Terminated
- 7 July 2023
- Reason
- Manufacturer issued a recall due to an EO indicator color. The indicator should change from red to blue signifying sterilization. However, on one case of product, the indicators did not change
- Distribution
- VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2473-2021
- McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121
Terminated Class III Medical devices
- Recall started
- 27 February 2019
- Terminated
- 21 May 2021
- Reason
- Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA, due to the packaging being too similar to domestically sourced products under the same branded label.
- Distribution
- Shipped to distribution centers located in AL, AR, AZ, CA, CO, FL, GA, HI, IL, KY, LA, MA, MN, MO, MS, NH, NJ, NY, OH, PA, SC, TN, TX, UT, VA, WA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1080-2019
- McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178¿TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, 178¿CK30
Terminated Class II Medical devices
- Recall started
- 4 September 2018
- Terminated
- 28 May 2024
- Reason
- Small hole at the end of the syringe is impeding suction of liquid.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0119-2019
- McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.
Terminated Class II Medical devices
- Recall started
- 2 July 2018
- Terminated
- 7 April 2023
- Reason
- The firm is recalling one lot of McKesson Powder Free Vinyl Exam Gloves because a sample of product from that lot did not meet certain release specifications. It is possible that certain gloves from this lot may not be of medical exam quality and, therefore, may not provide an effective barrier to infectious material.
- Distribution
- US Nationwide Distribution in the states of in AL, AR, IA, LA, OK, TX, UT, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2828-2018
- Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Medical exam glove for use by professional healthcare workers and/or consumers.
Terminated Class II Medical devices
- Recall started
- 17 November 2017
- Terminated
- 8 April 2020
- Reason
- Product not meeting the iodine assay level requirements to support 36 month expiration dating.
- Distribution
- US Distribution to states of: CO, FL, GA, KY, MI, MO, NC, NH, OH, TN, TX, WA, AND WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0932-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.