Z-2937-2018Class II

Duo-Flow XTP Straight Full Set, RMS02105 RMS02108

Name: Z-2937-2018 Duo-Flow XTP Straight Full Set, RMS02105 RMS02108
Creator: Medical Components, Inc dba MedComp
Published: 2018-07-12
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2018-07-12 / Terminated / root cause: manufacturing process

FDA source

Medical Components, Inc dba MedComp began a recall of Duo-Flow XTP Straight Full Set, RMS02105 RMS02108 on 2018-07-12. FDA classified it as Class II and gives the reason as "The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for...". 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-2937-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-12
Posted: 2018-08-25
Terminated: 2020-07-02
Recalling firm: Medical Components, Inc.
Product: Duo-Flow XTP Straight Full Set, RMS02105 RMS02108
Product code: MPB Catheter, Hemodialysis, Non-Implanted
Reason for recall: The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On July 12, 2018, the firm sent a Product Recall letter to its customers. Customers were provided with a full list of product codes and lot numbers and informed that those items had been recalled due to a potential for the suture wings to crack or break. Customers were informed that implanted catheters with intact suture wings do not need to be removed. However, an alternative method of catheter securement should be initiated for all implanted catheters, due to the potential for the suture wings to crack or break. Customers were instructed to return all unused recalled product to Medcomp. If product was further distributed, customers were asked to notify their sub-accounts. Contact your customer service representative for a Returned Goods Authorization (RGA) number if necessary. The phone number to call is 215-256-4201. Customers are asked to complete and return a customer response form included with the recall letter by fax (215-256-9191) or email ([email protected]).
Distribution: Nationwide distribution; worldwide distribution.
Product codes and lots: MKAC440 MCCH440

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2937-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2932-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-25
Z-2933-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-25
Z-2934-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-25
Z-2935-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-25
Z-2936-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-25
Z-2937-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-25
Z-2938-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-25
Z-2939-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-25
Z-2940-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-25
Z-2941-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-25
Z-2942-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-25

Product code MPB

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)