Z-2294-2010

Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003...

Name: Z-2294-2010 Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003...
Creator: Greatbatch Medical
Published: 2010-07-02
License: https://open.fda.gov/license/

Greatbatch Medical / initiated 2010-07-02 / Terminated / root cause: packaging

FDA source

Greatbatch Medical began a recall of Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006, 1000093-007... on 2010-07-02. The reason FDA records is "The outer sterile barrier (pouch) packaging for the 12 Fr device is not intact. No breaches in the inner sterile barrier (tray/tyvek lid) have been identified. The OptiSeal introducer and accessories sealed in the tray...". 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-2294-2010
Status: Terminated
Initiated: 2010-07-02
Posted: 2010-08-27
Terminated: 2011-12-17
Recalling firm: Greatbatch Medical
Product: Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006, 1000093-007. Sterilized using Ethylene Oxide. Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441 USA. The OptiSeal Valved PTFE Peelable Introducer is designed to reduce blood loss and air intake by providing hemostatic sealing at venous pressures. The device is offered in two configurations, one without a sideport and one with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock.
Product code: DYB Introducer, Catheter
Reason for recall: The outer sterile barrier (pouch) packaging for the 12 Fr device is not intact. No breaches in the inner sterile barrier (tray/tyvek lid) have been identified. The OptiSeal introducer and accessories sealed in the tray are sterile. Infection may result if a sterile field is contaminated by the outer surface of the inner tray.
Root cause tag: packaging
FDA root cause: Packaging
Action: Greatbatch Medical issued an "Urgent Medical Device Recall letter dated July 12, 2010 via email to consignees. The letter described the problem and affected device. Consignees were instructed to immediately discontinue distribution of the product and return the unused units to Greatbatch Medical and to notify their customers to immediately return unused units. For shipping assistance, questions or assistance in notifying accounts, contact Shannon Springer at 763 951-8244 or Kimberly Briggs, 716 759-5702.
Quantity in commerce: 211 5-pack boxes
Distribution: Worldwide Distribution: United States, including the states of MN and CA.
Product codes and lots: Model / lot number: 1000093-001 / W1515452; 1000093-002 / W1545383; 1000093-003 / W1519579, W1524143, W1515454; 1000093-004 / W1524146, W1519578, W1520649, W1515441; 1000093-005 / W1515455; 1000093-006 / W1515456; 1000093-007 / W1560536.

Product code DYB

K093232Class IIOptiseal Enpath Valved PTFE Peelable IntroducerGreat Batch Medical / cleared 2010-03-15

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)