Z-1127-2018Class II

Repair Kit, Ref Rpk-01, UDI 884908039856

Name: Z-1127-2018 Repair Kit, Ref Rpk-01, UDI 884908039856
Creator: Medical Components, Inc dba MedComp
Published: 2018-02-23
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2018-02-23 / Terminated / root cause: manufacturing process

FDA source

Medical Components, Inc dba MedComp began a recall of REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or... on 2018-02-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1127-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-23
Posted: 2018-03-19
Terminated: 2020-01-10
Recalling firm: Medical Components, Inc.
Product: REPAIR KIT, REF RPK-01, UDI 884908039856 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.
Product code: NFK Kit, Repair, Catheter, Hemodialysis
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On February 23, 2018, Medcomp distributed Product Recall and Distribution notices to international distributors via email and to U.S. facilities via courier service on February 26, 2018. Medcomp is requesting the return of all un-used affected product. Customers should immediately examine inventory and quarantine product subject to recall. If for any reason the product was further distributed, please identify the recipients and notify them at once of this product recall. Your notification may be enhanced by including a copy of this recall notification letter. Contact your customer service representative for a Returned Goods Authorization number if necessary by calling (215) 256-4201. Complete and return the Distribution Notice via fax (215-256-9191) or email ([email protected].
Quantity in commerce: 1575 kits
Distribution: 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.
Product codes and lots: Lot Numbers: MCCC310, MCCA800, MCFH990, MCFC040, MCFA160, MKAB730, MCFW690 , MCFS390, MKAB730, MCCC310, MCCC320, MCCL340, MCDD250, MCDD640, MCDP460 , MCCL340, MCDDZSO, MCDP460, MCDVOSO , MCDV820, MCFN890 & MCFS930.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1127-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1118-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-19
Z-1119-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-19
Z-1120-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-19
Z-1121-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-19
Z-1122-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-19
Z-1123-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-19
Z-1124-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-19
Z-1125-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-19
Z-1126-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-19
Z-1127-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-19

Product code NFK

K022570Class IIMedcomp Repair Kit, Model AspcrpkMedcomp / cleared 2002-10-31

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)