Class I Medical Device Recall: Symbios GOPump and GOBlock Kits

Recall Class: Class I

Date Recall Initiated: June 6, 2013

Product(s):

• Symbios GOPump in the GoPump Rapid Recovery System Kits
• Symbios GOBlock Kits

Lot numbers: All lots of GOPumps in the GoPump Rapid Recovery System kits and GOBlock kits manufactured with flow control components before July 2012. Please see the chart below listing all the lot numbers.

Manufacturing and Distribution Dates: The affected products were manufactured before July 2012 and distributed from April 27, 2011 to April 30, 2013.

Use:
The Symbios GOPump Rapid Recovery System is a disposable local pain management system that consists of a small balloon that is inflated with a local anesthetic medication. The medication is delivered slowly through tubes from the balloon to the surgical site.

Recalling Firm:
Symbios Medical Products, LLC
7301 Georgetown Road, Suite 150
Indianapolis, Indiana 46268

Distributor:
B. Braun Medical Inc.
901 Marcon Blvd.
Allentown, Pennsylvania 18109

Reason for Recall:
The affected products may have excessively high flow rates. As a result, medications could be delivered too quickly from the balloon to the surgical site and cause patient toxicity due to the rapid influx of medication. This can lead to serious illness, including seizure, abnormal heart rhythms and death. Elderly patients and patients with low body mass are at high risk of these complications.

Public Contact: Customers who purchased the product from B. Braun Medical, Inc. should contact B. Braun Customer Support at 1-800 227-2862.

Customers who purchased this product directly from Symbios Medical Products, call 1-317-319-0398 from 8:00 AM to 4:00 PM Eastern Standard Time to obtain directions for returning the product.

FDA District: Detroit District Office

FDA Comments:
Customers who have purchased the affected devices were notified by letter dated May 10, 2013 about the problem. Follow-up letters were sent on May 14, 2013 and May 30, 2013 notifying customers of additional recalled lots. The letters included directions to quarantine the product in a secure location and complete and return a verification form included in the letter.

B.Braun issued a customer notification on May 14, 2013. This notification directed customers to complete an attached “Product Removal Acknowledgement Form” and return using the provided self-addressed stamped envelop or by fax at 1-610-849-1197.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

GOPUMP AND GOBLOCK KITS SUBJECT TO RECALL

 

 

Range of Affected Kit Lot Numbers

 

Kit PN

From Kit Lot #

To Kit Lot #

Kit description

510042

11-100251

13-100128

GoPump kit 150mL, 2 mL/hr Epidural Catheter

510042-BP

12-101300

12-101300

GoPump kit 150mL, 2 mL/hr, Epidural Catheter BIOPATCH

510080-BP

11-100215

12-100508

GoPump kit 300mL, 2 mL/hr/side, 5″ Fenestrated Catheter and Biopatch

510110

11-100664

11-100664

GoPump kit 150mL, 2 mL/hr 2.5″ Fenestrated Catheter

510110-BP

11-100838

12-101560

GoPump kit 150mL, 2 mL/hr 2.5″ Fenestrated Catheter and Biopatch

510112-BP

11-100839

13-100225

GoPump kit 300mL, 2 mL/hr/side, 2.5″ Fenestrated Catheter BIOPATCH

510141-BP

12-100460

12-100673

GoPump kit 300mL, 2 mL/hr/side, 10″ Fenestrated Catheter BIOPATCH

510201-BP

12-100108

12-101538

GoPump kit 300mL, 2 ml/hr, 5″ Fenestrated Catheter BIOPATCH

510203-BP

12-101301

13-100611

GoPump kit 300ml, 4 ml/hr, Epidural Cath BIOPATCH

510204

11-100505

11-100665

GoPump kit 300ml, 4 ml/hr, 2.5″ Fenestrated Cath

510204-BP

11-100721

13-100680

GoPump kit 300ml, 4 ml/hr, 2.5″ Fenestrated Cath BIOPATCH

510205-BP

11-100722

13-100087

GoPump kit 300ml, 4 ml/hr, 5″ Fenestrated Catheter BIOPATCH

510349-BP

12-100935

12-100935

GoPump kit 300ml, 2 ml/hr, Epidural Catheter, 2.75″ Needle, BIOPATCH

510350

11-100353

12-100233

GoPump kit 150ml, 2 ml/hr, Epidural Catheter, 2.75″ Needle

510350-BP

12-100429

13-100047

GoPump kit 150ml, 2 ml/hr, Epidural Catheter, 2.75″ Needle, BIOPATCH

510401-BP

12-101045

12-101540

GoPump kit 300mL, 2 mL/hr/side, 7.5″ Catheters, BIOPATCH

510458

11-100618

13-100703

GOBlock Kit 600 ml, 10 ml/hr

510462-BP

11-100694

13-100092

GoPump kit 600mL, 2 mL/hr/side, 5″ Catheter, BIOPATCH

510472

11-100385

13-100354

GOBlock Kit 600 ml, 8 ml/hr

510491

11-100601

13-100705

GOBlock Kit 600 ml, 6 ml/hr

510545-BP

11-100718

13-100229

GoPump kit 300mL, 2 mL/hr/side, 5″ Fenestrated Catheter, BIOPATCH

510551-BP

11-100500

13-100672

GoPump kit 300mL, 4 ml/hr, 2.5″ Catheter, 2.75″ Needle, BIOPATCH

510556-BP

11-100779

12-101552

GoPump kit 150ml, 2 ml/hr, 2.5″ Catheter with 2.75″ Needle, BIOPATCH

510558-BP

12-100403

12-101343

GoPump kit 600mL, 2 mL/hr/side, 10″ Catheter, 6″ needle, BIOPATCH

510608

11-100695

12-101544

GOBlock kit 300mL, 4 ml/hr

510611

11-100302

13-100227

GOBlock Kit 300ml, 4 ml/hr

510612

11-100817

12-101475

GOBlock Kit 300ml, 6 ml/hr

510642

12-100616

13-100590

GoPump kit 300mL, 2 ml/hr

510643

12-100332

13-100183

GoPump kit 600mL, 2 mL/hr/side

510646

11-100632

12-101233

GoPump kit 600mL, SF

510644

11-100565

13-100169

GoPump kit 300mL, 2 ml/hr per side

510654

11-100833

13-100174

GOPump kit 150mL, 2 ml/hr

510031

11-100106

12-101133

GoPump 150mL, 2 mL/hr

510076

11-100222

12-101087

GoPump 300mL, 2 mL/hr/side

510180

11-100453

12-101003

GOPump 300 mL, 2 mL/hr

510121

11-100081

12-101406

GOPump 300 mL, 4 mL/hr

510447

11-100352

12-101272

GOPump 600 mL, 2 mL/hr / side

510449

11-100271

13-100137

GOBlock 600 mL, 8 mL/hr

510450

11-100351

12-101243

GOBlock 600 mL, 10 mL/hr

510490

11-100379

12-101132

GOBlock 600 mL, 6 mL/hr

510610

12-100163

12-100915

GOBlock 300 mL, 4 mL/hr

510613

11-100815

12-101060

GOBlock 300 mL, 6 mL/hr

510636

11-100538

12-100996

GOBlock 600 mL, SF