Medcomp 15.SF X 24CM Titan HD CATHETER recallZ-2940-2020 · Medical Components, Inc dba MedComp · initiated Jul 27, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medical Components, Inc dba MedComp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer
FDA root cause category: Under Investigation by firm
What the company is doing
Medcomp issued Urgent Medical Device Recall letter issued first class mail to the customers on July 27, 2020. Letter states reason for recall, health risk and action to take: " Immediately examine your inventory and quarantine all product subject to recall. " Options for disposition of affected product: o Return the product to Medcomp - Contact your Medical Components, Inc. customer service representative for a Returned Goods Authorization {RGA) number. The phone number to call is 215-256-4201. o Have individually packaged and sterilized 16F peelable introducers (MR191603) sent to use with the kits. Call your customer service representative and provide the number of kits you need the replacements introducers for. Same number as above. " Complete and return the Medical Device Recall Product Disposition Form. The form can be returned by fax {215-256-9191) or email ([email protected]). Contact Information for questions: Monday through Friday, 8:00 AM to 4:00 PM, Eastern Standard Time. Phone: 215-256-4201; Email: [email protected].
Recall details
- Recall number
- Z-2940-2020
- Status
- Terminated
- Initiated by the company
- Jul 27, 2020
- Recalling firm
- Medical Components, Inc dba MedComp
- Quantity
- 132 eaches
- Product code
- MSD
- FDA submissions
- K994105
- Distribution
- AZ, CA. FL. GA, NC, ND, NJ, NY, OH, PA, VA, WA
Product description
Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
Code information (models, lots, serial numbers)
Lot # MPCT670, UDI 884908129304 Exp. Date 12/20/2020
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERMEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETER THD155024Medical Components, Inc. · Catheter, hemodialysis, implanted1 recall1 death2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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