FDA Medical Device Recalls (openFDA)
Medical Components, Inc dba MedComp: Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M
- Recall number
- Z-2938-2018
- Recalling firm
- Medical Components, Inc dba MedComp
- Product
- Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M
- Status
- Terminated
- Initiated
- 2018-07-12
- Posted
- not on file
- Terminated
- 2020-07-02
- Reason
- 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
- 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 (complaints@medcompnet.com).
- Quantity
- not on file
- Distribution
- Nationwide distribution; worldwide distribution.
- Lot, serial or model codes
- MHJV260 MHMJ380 MHRC840 MHXF770 MJAZ910 MJDV230 MJLF440 MLCT530 MCAH650 MCAQ240 MCAW220 MCBC440 MCCJ920 MCCP260 MCDC910 MCDG320 MCDL590 MCDW940 MCFA540 MCFG000 MCFM820 MCFR060 MCFV060 MKAA520 MKAL360 MKAN510 MKAQ280 MKAZ530 MCAA590 MCAD760 MCAK990 MCBM860 MCBQ500 MCCA150 MCCG660 MCDD810 MCDG250 MCDJ980 MCDP910 MCDV760 MKAD560 MKAL370 MKBC340 MBZS180 MCAH050 MCAL000 MCBM870 MCBT030 MCCG580 MCCP590 MCDD570 MCDR280 MCDX060 MCFQ250 MCFS300 MCFT650 MCFX880 MKAB600 MKAM870 MBZY670 MCCT820 MCFQ150 MKBB070 MJLP070 MLDH060 MHLM190 MHRX850 MHSY930 MHYG710 MJCV440 MBYR870 MBZM650 MCAH670 MCAJ630 MCAQ250 MCAQ870 MCBA060 MCBD890 MCBX380 MCDF830 MCDL020 MCDR290 MCDX070 MCFA570 MCFD860 MCFH790 MKAF320 MKAG530 MKAK390 MKAL400 MKAM880 MKBA670 MCCT830 MHLJ070 MHRD620 MHRX860 MJKJ070 MCBC830 MCFK400
- 510(k) numbers
- ["K842416","K983511"]
- PMA numbers
- not on file
- Product code
- MPB
- Firm FEI
- 2518902
- Firm city
- Harleysville
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28