Device recall: a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50…
Class II FDA enforcement event 90336. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Mckesson Medical-Surgical Inc. Corporate Office started this device recall on 25 May 2022. The firm address in the FDA record is in Richmond, VA. FDA put the recall in Class II. FDA event 90336 has 55 product records. The first FDA enforcement report date is 31 Aug 2022. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
55 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1583-2022 | a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50 Tests-IVD. Part No. 0356-50. b. Coagulation Control Kit Coag-Sense PT / INR Test (Prothrombin Time Test) Low Level / High Level 10 Strips Part No. 03P69-10. | a. 27 boxes b. 1 box | Class II | Ongoing | 31 Aug 2022 |
| Z-1584-2022 | Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 Mfg: FERROSAN MEDICAL DEVICES A/S Indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical. | 2 cases | Class II | Ongoing | 31 Aug 2022 |
| Z-1585-2022 | HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP For ABX Pentra 400 Clinical Chemistry Analyzer 25 mL. Ref: 1220001769 | 3 each | Class II | Ongoing | 31 Aug 2022 |
| Z-1586-2022 | a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General Chemistry Creatinine Model Number: 1220001933 | a. 28 b. 22 | Class II | Ongoing | 31 Aug 2022 |
| Z-1587-2022 | a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests. Model Number: 5002. b. McKesson Consult Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Urine Sample 25 Tests Model Number: 5000. c. McKesson Medical-Surgical McKesson TEST KIT, PREG HCG… | a. 108 b. 838 c. 1225 | Class II | Ongoing | 31 Aug 2022 |
| Z-1588-2022 | Alere Toxicology TABLET, INSTANT BLUING F/DRUGSCREEN Model Number: 7875 | 1 Btl | Class II | Ongoing | 31 Aug 2022 |
| Z-1589-2022 | Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN) Urine Sample 25 Tests. Model Number: AWFTY-114. b. Alere Drugs of Abuse Test E-Z Split Key Cup 12-Drug Panel AMP, BAR, BUP, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PPX, THC Urine Sample 25 Tests Model Number: DOA-1127-041-19. c.… | a. unk b. 6 c. 1 d. 1 e. 67 f. 1 g. 10 h. 51 i. 27 j. 105 k. 4 l. 2 m. 3 | Class II | Ongoing | 31 Aug 2022 |
| Z-1590-2022 | a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model Number: 65035820, Model Number: USSCupA-12BUP300. b. Alcon Contact Lens Solution Opti Free Replenish 4 oz. Solution Model Number: 00065035604 Model Number: USSCupA-12BUP300. c. Alcon Contact Lens Solution Opti Free Replenish 10 oz. Solution… | a. 3 b. 91 c. 45 d. 2 | Class II | Ongoing | 31 Aug 2022 |
| Z-1591-2022 | Perifix LOR Syringe Perifix 8 mL Pouch Luer Lock Tip Without Safety Model Number: 332152 | 415 eaches | Class II | Ongoing | 31 Aug 2022 |
| Z-1592-2022 | B. Braun EVA Gravity Mixing Container 1000 mL Model Number: 2112363 | 1 Case | Class II | Ongoing | 31 Aug 2022 |
| Z-1593-2022 | Ultracell Eye Pledget Ultracell 2 X 6 X 1 mm, Sterile Model Number: 40825 | 2 Box | Class II | Ongoing | 31 Aug 2022 |
| Z-1594-2022 | Wetfield Eraser Bipolar Hemostatic Eraser Wet-Field Eraser 23 Gauge Tapered Model Number: 221265 | 1 box | Class II | Ongoing | 31 Aug 2022 |
| Z-1595-2022 | Cadwell Disposable Ground Electrodes Grounding Pad 1.25 X 1.75 Inch Dimensions, Disposable Model Number: 302288-000 | 2 Boxes | Class II | Ongoing | 31 Aug 2022 |
| Z-1596-2022 | Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Prefilled Syringe, Partial Fill 5 mL Fill in 10 mL Syringe Model Number: 513604 | 13 boxes | Class II | Ongoing | 31 Aug 2022 |
| Z-1597-2022 | MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare II General Chemistry Blood Lead Test Whole Blood Sample 48 Tests Model Number: 70-6762 | 81 kits | Class II | Ongoing | 31 Aug 2022 |
| Z-1598-2022 | Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectious Disease Immunoassay Strep A Test Throat / Tonsil Saliva Sample 25 Tests, Model Number: 5003. b. QUIDEL Sofia TEST KIT, STREP A+ SOFIA (25/KT 12KT/CS) Model Number: 20274. c. Alere SAN DIEGO INC McKesson TEST, KIT STREP A… | a. 214 kits b. 1cs c. 53 kits d. 4 bx e. 1 KT | Class II | Ongoing | 31 Aug 2022 |
| Z-1599-2022 | a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b. MERIT MEDICAL SYSTEMS Aspira Pleural / Peritoneal Drainage Kit Aspira 1000 mL Sterile Model Number: 4992301. | a. 123 b. 407 | Class II | Ongoing | 31 Aug 2022 |
| Z-1600-2022 | MERIT MEDICAL SYSTEMS Temno Soft Tissue Biopsy Device Temno 14 Gauge 6 cm Length Beveled Sharp Tip Model Number: T146 | 8 Boxes | Class II | Ongoing | 31 Aug 2022 |
| Z-1601-2022 | a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening Fecal Occult Blood Test (iFOB or FIT) Stool Sample 25 Tests, Model Number: 4487. b. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit McKesson Consult Colorectal Cancer Screening Fecal Occult Blood Test (FOBT) Stool Sample 100 Tests… | boxes: a. 20 b. 21 c. 4 | Class II | Ongoing | 31 Aug 2022 |
| Z-1602-2022 | NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL Bottle For Trophon EPR Disinfection System Model Number: N00037 | 31 Boxes | Class II | Ongoing | 31 Aug 2022 |
| Z-1603-2022 | Palmero Healthcare, LLC DisCide Ultra Surface Disinfectant Cleaner Quaternary Based Manual Pour Liquid 1 gal. Jug Herbal Scent NonSterile Model Number: 3565G | 8 Eaches | Class II | Ongoing | 31 Aug 2022 |
| Z-1604-2022 | TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN036437, IPN922677) | 5 each | Class II | Ongoing | 31 Aug 2022 |
| Z-1605-2022 | STERIS CORP Revital-Ox Resert Hydrogen Peroxide High-Level Disinfectant Revital-Ox RESERT RTU Liquid 4 Liter Container Max 21 Day Reuse Model Number: 4455AW | 20.25 CS | Class II | Ongoing | 31 Aug 2022 |
| Z-1606-2022 | a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model Number: 92211. | a. 5 kits b. 12 kits | Class II | Ongoing | 31 Aug 2022 |
| Z-1607-2022 | GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Model Number: 2002-000 | 6 each | Class II | Ongoing | 31 Aug 2022 |
| Z-1608-2022 | 3M COMPANY 3M PAD, GROUNDING SAFETY RING Model Number: 9165 | 8 cases | Class II | Ongoing | 31 Aug 2022 |
| Z-1609-2022 | MEDLINE INDUSTRIES Medline Catheter Insertion Tray Medline Foley Without Catheter Without Balloon Model Number: DYND10160 | 60 each | Class II | Ongoing | 31 Aug 2022 |
| Z-1610-2022 | MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, with Cover Model Number: DYND12200 | 1 Case | Class II | Ongoing | 31 Aug 2022 |
| Z-1611-2022 | MEDLINE INDUSTRIES Centurion IV Securement Kit Model Number: IVSSTK3 | 3 cases | Class II | Ongoing | 31 Aug 2022 |
| Z-1612-2022 | Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: 900-157 | 5 each | Class II | Ongoing | 31 Aug 2022 |
| Z-1613-2022 | Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610 | a. 30 each b. 0.3 cs | Class II | Ongoing | 31 Aug 2022 |
| Z-1614-2022 | a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800. b. METREX RESEARCH McKesson 14-Day Glutaraldehyde Solution DISINFECTANT, GLUTARALDEHYDE 14DAY (4GL/CS) MGM68 Model Number: 68-101400. c. METREX RESEARCH McKesson SOLUTION, GLUT 2.5% 28DAY QT (16/CS) PSS744 Catalog # 341. d. METREX… | 28 gallons b. 38 gal c. 16 qt d. 40 gal e. 124 gal | Class II | Ongoing | 31 Aug 2022 |
| Z-1615-2022 | MedSource IV Start kit, 8inch Extension Set IV START KIT, W/SITE LOC/8" EX100/CS Model Number: MS-80047 | 53 each | Class II | Ongoing | 31 Aug 2022 |
| Z-1616-2022 | B. BRAUN MEDICAL INC. Anesthesia Support Tray SUPPORT TRAY, +EXT SET(10/CS)ST200E Model Number: 332116 | 16 cases | Class II | Ongoing | 31 Aug 2022 |
| Z-1617-2022 | a. BECTON DICKINSON BD Vacutainer C&S Preservative Urine Tube TUBE, URINE COLL PLAS 4ML (100/BX 10BX/CS), Model Number: BD 364951. b. BECTON DICKINSON BD Vacutainer C&S Transfer Straw Kit TRANSFER STRAW KIT, URINE 4ML(50/BX 4BX/CS) Model Number: BD 364953. c. BECTON DICKINSON BD Vacutainer COLLECTION KIT, URINE… | a. 25 bx b. 53 bx c. 31 cs | Class II | Ongoing | 31 Aug 2022 |
| Z-1618-2022 | a. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 3.5ML PLAS VACUTAINER (100/BX), Model Number: 367983. b. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP RED/GRY8.5ML PLAS VACUTAINER (100/BX Model Number: 367988. c. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 5MLPLAS… | a. 67 boxes b. 131 c. 51 d. 121 e. 2 f. 38 g. 16 h. 240 i. 17 j. 41 | Class II | Ongoing | 31 Aug 2022 |
| Z-1619-2022 | a. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML (60/BX 16BX/CS), Model Number: MIS-1130. b. MEDEFIL INC McKesson SALINE IV FLUSH, SYR NORMAL 10ML/12ML .9% (60/BX 16BX/CS) Model Number: 191-MIS-1130. | a. 20 Boxes b. 1 bx | Class II | Ongoing | 31 Aug 2022 |
| Z-1620-2022 | a. METREX RESEARCH CORP CaviCide1 DISINFECTANT, CLNR CAVICIDE1 1GL (4/CS) METREX, Model Number: 13-5000. b. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE 8OZ SPRAY MX-1008 METREX Model Number: 13-1008. c. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE GL MX-1000 METREX Catalog #13-1000. d. METREX… | 50cs b. 38 c. 519gal d. 1671 e. 43.25cs f. 33btl g. unk | Class II | Ongoing | 31 Aug 2022 |
| Z-1621-2022 | METREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS) Model Number: 10-4025 | 5 Boxes | Class II | Ongoing | 31 Aug 2022 |
| Z-1622-2022 | Dynarex PAD, NAIL POLISH REMOVER (100/BX 10BX/CS) DYNREX Catalog # 1501 | 2 Boxes | Class II | Ongoing | 31 Aug 2022 |
| Z-1623-2022 | a. DERMA SCIENCES, INC. NG Strip FASTENER, NASAL TUBE IND WRAP(25/BX), Catalog NG25. b. DERMA SCIENCES, INC. Surgitube BANDAGE, GAUZE #2P 7/8"X50YDS DERSCI Catalog GL-242. c. DERMA SCIENCES, INC. Surgilast TUBE NET SZ3 MED 10YDS/EA HAND, ARM, LEG, FOOT SURGILAST Catalog # GL103. d. DERMA SCIENCES, INC. Surgitube &… | a. 772 b. 9 c. 1 d. 1 | Class II | Ongoing | 31 Aug 2022 |
| Z-1624-2022 | FISHER SCIENTIFIC Sure-Vue PIPETTE, RPR DISPENSING (500/PK) Catalog # 23038015 | 3 pk | Class II | Ongoing | 31 Aug 2022 |
| Z-1625-2022 | BEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD PED 7MMX20MM(10/BX) BVRVIS Catalog #30316-C | 3 Boxes | Class II | Ongoing | 31 Aug 2022 |
| Z-1626-2022 | BEAVER-VISITEC INTERNATIONAL, INC. Visitec CANNULA, LASIK IRR (10/BX)BVRVIS Catalog #585278 | 1 Box | Class II | Ongoing | 31 Aug 2022 |
| Z-1627-2022 | FISHER SCIENTIFIC Fisherbrand SWAB TRANS STUARTS DBL 50BX Catalog #1490721 | 25 Boxes | Class II | Ongoing | 31 Aug 2022 |
| Z-1628-2022 | FISHER SCIENTIFIC Aseptic Control LUBRICATING JELLY PAP TEST 4OZ(12/PK) Catalog #22998006 | 7 packs | Class II | Ongoing | 31 Aug 2022 |
| Z-1629-2022 | BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Cleaner REAGENT, CLEANER FP DXH 10LCOULTR Catalog #628023. c. DxH 500 Series Lyse LYSE, VERSA SOL DXH 500 SERIES(0.5L/KT) Catalog # B36846. d. DxH 500 Series Cleaner CLEANER, COULTER CLENZ DXH 500SERIES… | a. 11 b. 13 c. 15 d. 33 | Class II | Ongoing | 31 Aug 2022 |
| Z-1630-2022 | CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNTURN Catalog # CKF105L | Class II | Ongoing | 31 Aug 2022 | |
| Z-1631-2022 | COOPER SURGICAL Milex PESSARY, RING MILEX INCONT FLEXIBLE SZ6 1 3/4" Catalog # MXPCON06 | 1 each | Class II | Ongoing | 31 Aug 2022 |
| Z-1632-2022 | MORRISON MEDICAL Morrison Medical OB KIT, HARD PK SEALED W/CARDBOARD BX MORMED Catalog #0967NL | 16 each | Class II | Ongoing | 31 Aug 2022 |
| Z-1633-2022 | DYNAREX Dynarex SWABSTICK, PVP (3/PK 25/BX 10BX/CS) Catalog #1202 | 197 boxes | Class II | Ongoing | 31 Aug 2022 |
| Z-1634-2022 | Dynarex SWAB, LEMON GLYCERIN (3/PK 25PK/BX 10BX/CS) DYNREX Catalog # 1216 | 135.08 boxes | Class II | Ongoing | 31 Aug 2022 |
| Z-1635-2022 | DYNAREX DynaLube LUBRICATING JELLY, STR 2.7GM (144/BX 12BX/CS) Catalog #1250 | 17.5 boxes | Class II | Ongoing | 31 Aug 2022 |
| Z-1636-2022 | FISHER SCIENTIFIC Fisherbrand SWAB, ROUND BOTTOM CLR (50/PK)FSHSCI Catalog # 1490712 | 154 pack | Class II | Ongoing | 31 Aug 2022 |
| Z-1637-2022 | MEDICAL CHEMICAL CORPORATION Total-Fix STOOL COLL KIT, TOTAL FIX PARASITOLOGY (100/CS) Catalog # NC0585129 | 1 case | Class II | Ongoing | 31 Aug 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 55Median of the firm: 3
- Events of the firm on the register
- 15
Other events of the firm
Mckesson Medical-Surgical Inc. Corporate Office: all 15 events
Official channels
- FDA enforcement report Z-1583-2022The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 90336. https://recallregister.com/fda/ii/90336/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide
- What quantity of product is in FDA event 90336?
- The event has 55 product records. The first record gives this quantity:
a. 27 boxes b. 1 box
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.