Food, drugs, devices › Baxter Healthcare Corp.

Device recall: Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.

FDA enforcement event 65183 · Class II · initiated 15 May 2013 · status Terminated · terminated 16 Jun 2015

DeviceVoluntary: Firm initiated3 product recordsDeerfield, IL

Baxter Healthcare Corp. (Deerfield, IL) initiated this device recall on 15 May 2013; FDA lists 3 product records under event 65183, classified Class II.

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. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 16 Jun 2015. Initiation: voluntary: firm initiated. Baxter Healthcare Corp. has 83 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

Baxter Healthcare Corp., Deerfield, IL.

Reason for recall

"A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging."

Distribution

"US Nationwide Distribution"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1682-2013	Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including…	356,728 units	Class II	Terminated	17 Jul 2013
Z-1683-2013	Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98" (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic…	530,488 units	Class II	Terminated	17 Jul 2013
Z-1684-2013	Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Length 99" (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic…	249,576 units	Class II	Terminated	17 Jul 2013

Context

90%of 2013 device events are Class II1,236 events that year

3product records in this eventfirm median: 1

83events on this register for the firm

Other enforcement events for Baxter Healthcare Corp.

Initiated	Product (first record)	Type	Class	Records
1 Sep 2017	Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479	Device	Class II	1
12 Oct 2016	GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dial	Device	Class II	1
28 Sep 2016	sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 3	Device	Class II	3
24 Jun 2016	Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106	Device	Class II	1
23 May 2016	PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy	Device	Class II	1
12 May 2016	COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemos	Device	Class II	3
21 Apr 2016	GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Devic	Device	Class II	5
12 Apr 2016	Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL,	Drug	Class II	1
16 Feb 2016	Automated peritoneal dialysis (APD) cycler	Device	Class II	1
5 Feb 2016	0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Produc	Drug	Class II	1

All 83 events for Baxter Healthcare Corp.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging."

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: "US Nationwide Distribution"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 16 Jun 2015. "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.