CLASS II Device recall · Reported 28 Mar 2018 · FDA Enforcement Report
12F Modified Tesio Catheter Set recalled by Medical Components
Medical Components is recalling 12F Modified Tesio Catheter Set, distributed nationwide in the US. The recall was initiated on 23 Feb 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1123-2018
- FDA event ID
- 79436
- Recalling firm
- Medical Components, Harleysville, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Feb 2018
- FDA classified
- 19 Mar 2018
- Reported
- 28 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 23 Feb 2018 | Recall initiated by company | |
| 19 Mar 2018 | Classified by FDA | +24 days |
| 28 Mar 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Where it was distributed
Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, VT, WA & WI. International: Australia, Austria, Belgium, Canada, Ecuador, France, Germany, Great Britain Greece, Ireland, Israel, Italy, Netherlands, Netherlands, South Africa, Spain Sweden, Turkey & United Arab Emirates.
Nationwide AlabamaArkansasCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIllinoisIndianaKansasLouisianaMassachusettsMarylandMichiganMinnesotaMississippiNorth CarolinaNew HampshireNew Jersey
Questions about this recall
Is 12F Modified Tesio Catheter Set recalled?
Yes. Medical Components recalled 12F Modified Tesio Catheter Set on 23 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-1123-2018.
Why was it recalled?
There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
Which lots are affected?
Lot Numbers: MCBM830, MCDZ620 & MCDP130.
Where was it sold?
Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, VT, WA & WI. International: Australia, Austria, Belgium, Canada, Ecuador, France, Germany, Great Britain Greece, Ireland, Israel, Italy, Netherlands, Netherlands, South Africa, Spain Sweden, Turkey & United Arab Emirates.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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