Prytime Medical recalls Reboa Catheter Introducer Kit (KT1835C) due to possible 21G needle instead of 18G. Using this wrong needle may cause procedure delays or injury during vascular access.
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.
Prytime Medical is recalling their Reboa Catheter Introducer Kit (KT1835C) because it might contain a 21G needle instead of the required 18G needle. This could lead to procedure delays or injury if the wrong needle is used during vascular access.
The kit may include a 21G access needle instead of the 18G needle. If the 21G needle is used, the guidewire won't pass through the needle properly, which can cause procedure delays or injury during vascular access.
Healthcare professionals using the kit for vascular access procedures are most at risk. Patients undergoing procedures with this kit could experience delays or injury if the wrong needle is used.
Check for the kit's reference number KT1835C. The kit contains a needle labeled 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA. It was sold with a UDI code (01) 0 0863092 00010 1 and lot number MFG 3590.
Verify the needle size is 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA as listed in the kit description.
Reach out to Prytime Medical for assistance with the recall if you have the kit.
The kit may contain a 21G needle instead of the correct 18G needle, which could cause procedure delays or injury during vascular access.
Check the kit contents to ensure the needle is 18 GA x 7 CM ECHOGENIC, STERILE. Contact Prytime Medical for further assistance.
Using the wrong needle could cause procedure delays or injury, but the recall does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send Prytime Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0959-2021 — Prytime Medical Prytime Medical Hello, I own a Prytime Medical that is covered by recall Z-0959-2021 from Prytime Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
