Z-0959-2021Class II

PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC...

Name: Z-0959-2021 PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC...
Creator: Prytime Medical Devices, Inc.
Published: 2020-12-14
License: https://open.fda.gov/license/

Prytime Medical Devices, Inc. / initiated 2020-12-14 / Terminated

FDA source

Prytime Medical Devices, Inc. began a recall of PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER... on 2020-12-14. FDA classified it as Class II and gives the reason as "There is a potential that a catheter convenience set contains a 21G access needle instead of the correct 18G needle. If the 21G needle is used to gain vascular access then the guidewire included in the kit will not pass...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0959-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-14
Posted: 2021-02-05
Terminated: 2022-09-28
Recalling firm: Prytime Medical Devices, Inc.
Product: PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, STERILE 1 EA., PREFILLED, STERILE FIELD SALINE SYRINGE, 10 ML, 4 EA, CLAMP, 5 FR, STERILE, 1 EA, SCALPEL, #11SS, STERILE, 1 EA, SUTURE, NYLON, 18", 2-0, REVERSE CUTTING, STERILE 1 EA, THREE QUARTER DRAPE, STERILE 1 EA, INSERT, SALINE 1 EA, INSERT, CLAMP 1 EA UDI: (01) 0 0863092 00010 1
Product code: OFC Catheter Introducer Kit
Reason for recall: There is a potential that a catheter convenience set contains a 21G access needle instead of the correct 18G needle. If the 21G needle is used to gain vascular access then the guidewire included in the kit will not pass through the access needle to facilitate insertion of an introducer sheath and could therefore cause procedure delay or injury.
FDA root cause: Mixed-up of materials/components
Action: On 12/14/2020, Prytime Medical sent an "Urgent Medical Device Recall Notification" to affected consignees via FedEx. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1) Please immediately review your inventory for the recalled lot specified in this notification. Quarantine and do NOT use this lot. 2) If you have an urgent need for this kit, and dont have an alternative lot available then please ensure that you have a backup 18 gauge access needle readily available at the point of use. Do not use the 21G access needle in the kit. 3) Immediately complete and return the attached Customer Response Form to the contact on the form. a. Please specify the number of affected kits in your possession. b. Prytime will promptly contact you to arrange return and replacement shortly after receiving the completed form. 4) Share this recall notification with any users of the product within your facilities, or anyone else you may have sent the product to, in order to ensure they are also aware of this recall. 5) Report any adverse health consequences experienced with the use of this product to Prytime using the attached form, or by email at [email protected], or by phone at (210) 340-0116. If you have any questions or discover any additional REBOA Convenience Set KT1835C Lot MFG3590 at your facility please contact the Recall Coordinator by phone at (210) 340-0116, or by email at [email protected].
Distribution: US Nationwide distribution including in the states of NJ, NY, CA, TX, MI, MO, CO, MI, VA, DE, TN, MO, MT, AZ, FL, WI, SC, WA, TX, CT, IN, PA, ME, WI, MA, GA, OH, AR, UT, NY OUS: None
Product codes and lots: Lot # MFG 3590

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0959-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0959-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-05

Product code OFC

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)