Aspen Surgical Products, Inc.: 19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed wound suction drainage

Recall number

Z-1433-2014

Recalling firm

Aspen Surgical Products, Inc.

Product

19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed wound suction drainage

Status

Terminated

Initiated

2014-03-20

Posted

2014-04-07

Terminated

2014-11-25

Reason

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

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.

Quantity

not on file

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.

Lot, serial or model codes

Product Number 340019

510(k) numbers

not on file

PMA numbers

not on file

Product code

GCY

Firm FEI

3002750084

Firm city

Caledonia

Firm state

MI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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