Z-2768-2017Class II

DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure...

Name: Z-2768-2017 DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure...
Creator: Medtronic Perfusion Systems
Published: 2017-06-22
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2017-06-22 / Terminated / root cause: packaging

FDA source

Medtronic Perfusion Systems began a recall of DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery on 2017-06-22. FDA classified it as Class II and gives the reason as "Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2768-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-22
Posted: 2017-07-10
Terminated: 2020-07-22
Recalling firm: Medtronic Perfusion Systems
Product: DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
Product code: DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Reason for recall: Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Medtronic sent an Urgent Medical Device Recall letter dated June 22, 2017, to all affected consignees, both in the US, via 2-Day UPS Mail, and OUS, via local methods. Consignees were asked to quarantine and return any affected product. No recommendations were made for patients who have undergone procedures using affected product. US consignees were asked to complete and return a recall notification confirmation certificate to fax 651-367-0612, indicating that they were informed of the recall and executed the appropriate action. Customers with questions were instructed to contact Customer Service at 1-800-854-3570. For questions regarding this recall call 763-526-2494.
Quantity in commerce: 63053 (48180 US) (14873 OUS)
Distribution: Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Denmark, El Salvador, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Macedonia, Moldova, Netherlands, New Zealand, Nigeria, Norway, Poland, Romania, Russian Federation, Slovenia, Spain, Thailand, Turkey, & United Kingdom.
Product codes and lots: Model No. 61000: Product UPN: 20613994846604: Lot No. 2016020865, 2016030859, 2016031538, 2016040539, 2016040859, 2016050268, 2016050556, 2016051179, 201605C063, 201605C064, 201605C065, 201605C066, 201605C067, 201605C068, 201605C069, 2016060275, 2016060525, 2016060896, 2016060897, 2016061082, 2016061083, 2016061084, 2016061476, 2016061477, 2016061478, 2016061479, 2016061480, 2016070727, 2016070744, 2016070753, 2016070962, 2016070963, 201607C046, 201607C047, 2016080349, 2016081585, 2016081586, 2016081587, 2016090237, 2016090593, 2016090594, 2016091409, 2016091410, 2016100571, 2016100572, 2016100875, 2016100876, 2016110851, 2016110852, 2016111130, 2016111131, 2016111132, 2016111133, 2016120836, 201612C037, 2017010052, 2017020120, 2017020122, 2017021065, 2017021066, 2017030114, 2017030115, 2017030116, 2017030117, 2017030118, 2017030119, 2017030595, 2017030951, 2017031135, 201703C055. Model 62000: Product UPN: 20613994846642: Lot No. 2016040236, 2016040540, 2016041196, 2016051245, 201605C015, 201605C016, 2016060226, 2016060526, 2016060899, 2016061085, 2016061086, 2016061482, 2016070542, 2016070964, 2016070965, 2016080350, 2016081588, 2016081589, 2016091146, 2016100654, 2016110453, 2016110854, 2016120837, 2017010583, 2017010945, 201701C037, 2017021067, 2017021068, 2017030596, 201703C104, 2017040147.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2768-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2764-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-25
Z-2765-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-25
Z-2766-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-25
Z-2767-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-25
Z-2768-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-25

Product code DXS

K852232Class IIPressure Display Box #60000/Tubing Set #61000Dlp, Inc. / cleared 1985-08-09

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)