Cypress Medical Products LLC
Richmond, VA, US
CYPRESS MEDICAL PRODUCTS LLC appears in FDA device records in Richmond, VA. FDA records list 26 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 20 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 26 510(k) clearances for Cypress Medical Products LLC between 1989 and 2002. The busiest year on record is 1989, with 10. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 10 |
| 1990 | 2 |
| 1992 | 4 |
| 1994 | 1 |
| 1995 | 4 |
| 1998 | 3 |
| 2001 | 1 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K021676 | CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL | HIB | Substantially Equivalent | |
| K012282 | STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE | LYZ | Substantially Equivalent | |
| K972899 | CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER | DXQ | Substantially Equivalent | |
| K972849 | ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) | FXX | Substantially Equivalent | |
| K972883 | ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) | FXX | Substantially Equivalent | |
| K952367 | CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K950254 | CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K950109 | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER | FCM | Unknown | |
| K950092 | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY | FCM | Unknown | |
| K945082 | CYPRESS MEDICAL PRODUCTS STETHOSCOPE | LDE | Substantially Equivalent | |
| K921988 | LACERATION REPAIR TRAY | MDM | Unknown | |
| K920480 | DRESSING CHANG & WOUND MANAGEMENT | FRG | Unknown | |
| K914475 | IV START KIT | LRS | Unknown | |
| K915430 | SKIN STAPLE REMOVER KIT | GDT | Unknown | |
| K896129 | URINARY LEG BAG | FAQ | Substantially Equivalent | |
| K897054 | CLINICAL MERCURY THERMOMETER | FLK | Substantially Equivalent | |
| K890728 | STERILE IRRIGATION TRAYS | KYZ | Unknown | |
| K890465 | CLOSED SYSTEM URINARY DRAINAGE BAG | EYZ | Substantially Equivalent | |
| K891941 | PATIENT EXAMINATION GLOVES (VINYL) | LYZ | Substantially Equivalent | |
| K892086 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | Substantially Equivalent | |
| K890729 | SUTURE REMOVAL KIT | LRO | Substantially Equivalent | |
| K891860 | PATIENT EXAMINATION GLOVES (VINYL) | LYZ | Substantially Equivalent | |
| K890770 | STERILE LAPAROTOMY SPONGES | EFQ | Substantially Equivalent | |
| K890709 | O.R. TOWELS (STERILE) | KKX | Substantially Equivalent | |
| K890727 | NON-STERILE, BULK GAUZE SPONGES | EFQ | Substantially Equivalent | |
| K890726 | TRACHEOSTOMY CARE AND CLEANING KITS | LRO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1451040 | 1451040 | CYPRESS MEDICAL PRODUCTS LLC | 9954 Mayland Dr, Richmond, VA 23233 US | 2026 | No device listings on this registration |
| 3012232810 | 3012232810 | CYPRESS MEDICAL PRODUCTS LLC | 21500 Harvill Ave, Perris, CA 92570 US | 2026 | No device listings on this registration |
| 3030975187 | 3030975187 | CYPRESS MEDICAL PRODUCTS LLC | 1338 Interstate Centre Blvd, Suite 100, Ellabell, GA 31308 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FAQBag, Urine Collection, Leg, For External Use, Sterile
- DXQBlood Pressure Cuff
- KKXDrape, Surgical, Antimicrobial
- EFQGauze/Sponge, Internal
- LROGeneral Surgery Tray
- LRSI.V. Start Kit
- MDMInstrument, Manual, Surgical, General Use
- LYYLatex Patient Examination Glove
- FXXMask, Surgical
- HIBSpeculum, Vaginal, Nonmetal
- GDTStaple, Removable (Skin)
- LDEStethoscope, Manual
- KYZSyringe, Irrigating (Non Dental)
- EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
- FLKThermometer, Clinical Mercury
- FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- LYZVinyl Patient Examination Glove
- FRGWrap, Sterilization
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3185-2024 | Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008 | 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. | Class II | Open, Classified | |
| Z-3184-2024 | BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025 | 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. | Class II | Open, Classified | |
| Z-3154-2024 | General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C | 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. | Class II | Open, Classified | |
| 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) | Affected syringes lack FDA clearance. | Class II | Open, Classified | |
| Z-2473-2021 | McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121 | 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 | Class II | Terminated | |
| Z-1080-2019 | McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, 178CK30 | 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. | Class III | Terminated | |
| 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. | Small hole at the end of the syringe is impeding suction of liquid. | Class II | Terminated | |
| 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. | 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. | Class II | Terminated | |
| 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, Cypress Item # 82-15 Manual surgical instrument for general use. | Product not meeting the iodine assay level requirements to support 36 month expiration dating. | Class II | Terminated | |
| Z-0741-2017 | McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140 | A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed. | Class II | Terminated | |
| Z-1273-2013 | Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by Owens & Minor, Mechanicsville, VA. The product is used to clamp the umbilical cord after childbirth. | Cypress Medical Products LLC is voluntarily recalling one lot of the Owens and Minor (O&M) Umbilical Cord Clamps because recent complaints indicate the clamps are breaking upon use. The product may not perform as intended. | Class II | Terminated | |
| Z-0681-2012 | Zee Clear Vinyl Medical Examination Gloves, Powder Free, X-Large, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine, CA 92606, Made in China; Zee Part No.: 3063 Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants | The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects. | Terminated | ||
| Z-0680-2012 | Zee Clear Vinyl Medical Examination Gloves, Powder Free, Large, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine, CA 92606, Made in China; Zee Part No.: 3062 Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants | The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects. | Terminated | ||
| Z-0679-2012 | Zee Clear Vinyl Medical Examination Gloves, Powder Free, Medium, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine, CA 92606, Made in China; Zee Part No.: 3061 Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants | The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects. | Terminated | ||
| Z-0368-05 | McKesson Medi-Pak Elastic Bandages, Premium, Sterile; rolled elastic bandage, single patient use, knit, single self closure, latex-free; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in Canada, Packaged, sterilized and inspected in the U.S.A.; the elastic bandages are packaged in paper/poly pouches, 36 bandages per case in the following sizes: Product Number 16-1033-2-STR, 2' wide; 16-1033-3-STR, 3' wide; 16-1033-4-STR, 4' wide; and 16-1033-6-STR, 6' wide | The elastic bandages which are labeled sterile have a lack of assurance of sterility. | Terminated | ||
| Z-0646-05 | Manual Mechanical Wheelchair, 22'' seat, , maximum patient weight: 350 lbs.; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in China; the wheelchairs were sold in the following configurations: reorder 16-7952: Removable Desk Arm, Swing Footrest reorder 16-7953: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7954: Removable Full Arm, Elevating Adjustable Legrest | The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair. | Terminated | ||
| Z-0645-05 | Manual Mechanical Wheelchair, 20'' seat, , maximum patient weight: 350 lbs.; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in China; the wheelchairs were sold in the following configurations: reorder 16-7942: Removable Desk Arm, Swing Footrest reorder 16-7943: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7944: Removable Full Arm, Elevating Adjustable Legrest | The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair. | Terminated | ||
| Z-0644-05 | Manual Mechanical Wheelchair, 24'' seat, , maximum patient weight: 450 lbs.; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in China; the wheelchairs were sold in the following configurations: reorder 16-7920: Removable Desk Arm, Swing Footrest reorder 16-7921: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7922: Removable Full Arm, Elevating Adjustable Legrest | The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair. | Terminated | ||
| Z-0643-05 | Manual Mechanical Wheelchair, 16'' seat, , maximum patient weight: 250 lbs.; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in China; the wheelchairs were sold in the following configurations: reorder 16-7910: Fixed Full Arm, Swing Footrest reorder 16-7911: Fixed Full Arm, Elevating Adjustable Legrest reorder 16-7912: Removable Desk Arm, Swing Footrest reorder 16-7913: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7914: Removable Full Arm, Elevating Adjustable Legrest | The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair. | Terminated | ||
| Z-0642-05 | Manual Mechanical Wheelchair, 18'' seat, , maximum patient weight: 250 lbs.; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in China; the wheelchairs were sold in the following configurations: reorder 16-7901: Fixed Full Arm, Fixed Footrest reorder 16-7902: Fixed Full Arm, Swing Footrest reorder 16-7903: Fixed Full Arm, Elevating Adjustable Legrest reorder 16-7904: Removable Desk Arm, Swing Footrest reorder 16-7905: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7906: Removable Full Arm, Elevating Adjustable Legrest | The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain