Device recall: Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.

FDA enforcement event 79301 · Class II · initiated 15 Feb 2018 · status Terminated · terminated 31 Oct 2018

DeviceVoluntary: Firm initiated1 product recordResearch Triangle Park, NC

FDA enforcement event 79301 is a device recall by Teleflex Medical of Research Triangle Park, NC, initiated 15 Feb 2018 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 31 Oct 2018. Initiation: voluntary: firm initiated. Teleflex Medical has 82 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Teleflex Medical, Research Triangle Park, NC.

Reason for recall

"Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled."

Distribution

"KS"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1193-2018	Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.	12 units	Class II	Terminated	4 Apr 2018

Context

92%of 2018 device events are Class II1,074 events that year

1product record in this eventfirm median: 1

82events on this register for the firm

Other enforcement events for Teleflex Medical

Initiated	Product (first record)	Type	Class	Records
30 Oct 2019	HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are in	Device	Class II	1
8 Oct 2019	Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-005 - Product Usage: T	Device	Class II	3
4 Oct 2019	WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are de	Device	Class II	2
30 Jul 2019	Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tu	Device	Class I	8
1 Jul 2019	Rusch EasyCath Kit	Device	Class II	1
24 May 2019	Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management	Device	Class I	8
10 May 2019	Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) REF 870-07KI	Device	Class I	1
1 Apr 2019	RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0	Device	Class II	5
27 Feb 2019	Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500	Device	Class III	2
14 Jan 2019	RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device	Device	Class III	2

All 82 events for Teleflex Medical

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "KS"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 31 Oct 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.