Z-1431-2014Class II

10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed...

Name: Z-1431-2014 10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed...
Creator: Aspen Surgical Products, Inc.
Published: 2014-03-20
License: https://open.fda.gov/license/

Aspen Surgical Products, Inc. / initiated 2014-03-20 / Terminated / root cause: packaging

FDA source

Aspen Surgical Products, Inc. began a recall of 10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage on 2014-03-20. FDA classified it as Class II and gives the reason as "The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices". 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-1431-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-20
Posted: 2014-04-07
Terminated: 2014-11-25
Recalling firm: Aspen Surgical Products, Inc.
Product: 10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Product code: GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Reason for recall: The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Aspen Surgical sent an Urgent Medical Device Recall letter dated March 20, 2014, to all affected customers and will be carried out at the distributor and retailer level, which can include doctor's offices, hospitals, and clinics. The distributor was instructed to contact their local FDA District office, conduct a sub-recall and to forward this Recall Notification and Response form to their retailers. A written notification to the consignees was sent by certified mail. Aspen has given the customers the option to either 1.) Return the product 2.) Destroy the product with a Certificate of Destruction to be provided to Aspen. Any returned product to Aspen will be put on MRB and dispositioned by Quality. The returned product will not be reprocessed. In order to determine effectiveness of the recall, any consignee that does not return the response form and/or product, will be contacted within three weeks of receipt of the Recall letter. Non-responders will be contacted a total of three (3) times in order to verify the effectiveness of the recall activity. Customers with questions were instructed to call 888-364-7004, ext 177 or 1-888-364-7004, ext. 156. For questions regarding this recall call 616-698-7100.
Distribution: Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.
Product codes and lots: Product Number 340007

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1431-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1417-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-07
Z-1418-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-07
Z-1419-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-07
Z-1420-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-07
Z-1421-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-07
Z-1422-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-07
Z-1423-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-07
Z-1424-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-07
Z-1425-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-07
Z-1426-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-07
Z-1427-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-07
Z-1428-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-07
Z-1429-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-07
Z-1430-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-07
Z-1431-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-07
Z-1432-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-07
Z-1433-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-07
Z-1434-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-07
Z-1435-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-07

Product code GCY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)