Recall Z-1422-2014
Aspen Surgical Products, Inc. · initiated March 20, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems
Codes / lots: Product Number 310101
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.
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-1422-2014
- Initiated
- March 20, 2014
- Posted by FDA
- April 7, 2014
- Terminated
- November 25, 2014
- Product code
- GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- 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.
- Recalling firm
- Aspen Surgical Products, Inc., Caledonia, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1417-2014 Class II | 7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case)…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | 03/20/2014Terminated |
| Z-1418-2014 Class II | 10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case)…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | 03/20/2014Terminated |
| Z-1419-2014 Class II | 10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | 03/20/2014Terminated |
| Z-1420-2014 Class II | 15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | 03/20/2014Terminated |
| Z-1421-2014 Class II | Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | 03/20/2014Terminated |
| Z-1423-2014 Class II | 7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) Intended for…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | 03/20/2014Terminated |
| Z-1424-2014 Class II | 10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | 03/20/2014Terminated |
| Z-1425-2014 Class II | 15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | 03/20/2014Terminated |
| Z-1426-2014 Class II | 19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | 03/20/2014Terminated |
| Z-1427-2014 Class II | 10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | 03/20/2014Terminated |
| Z-1428-2014 Class II | 10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | 03/20/2014Terminated |
| Z-1429-2014 Class II | 10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case)…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | 03/20/2014Terminated |
| Z-1430-2014 Class II | 7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case)…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | 03/20/2014Terminated |
| Z-1431-2014 Class II | 10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case)…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | 03/20/2014Terminated |
| Z-1432-2014 Class II | 15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | 03/20/2014Terminated |
| Z-1433-2014 Class II | 19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | 03/20/2014Terminated |
| Z-1434-2014 Class II | 7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | 03/20/2014Terminated |
| Z-1435-2014 Class II | 7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) 10…The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound… | 03/20/2014Terminated |