Medtronic Synchromed II Programmable Pump , Medtronic Inc., Minneapolis, MN 55432-5604 20 ml Pumps Model 8637-20 The imp

FDA device recall Z-2181-2008 · posted 2008-09-03 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

SynchroMed II pumps (non-implanted) may have been manufactured without propellant.

Action taken

Consignees were contacted by "Medtronic Urgent: Medical Device Recall" letters dated May 2008. The SynchoMed II pumps may have been manufactured without propellant. This device is limited to non-implanted SynchoMedl II pumps. Physcians should not impant these potentially affected pumps. The notifcation provides information on how to identify Pumps Without Propellant, Patient Management Recommendations and Additional Resources. A separate letter was issued to Inventory/Risk Mangers. The letter described the product and problem and included a section on the Product Recall, Returning Product and Accounting for Lost Inventory Product. Contact Medtronic at 1-800-707-0933.

Root cause

Process control

Status

Terminated

Product code

LKK

Quantity affected

7468

Distribution

AK, AL, AR, AZ, CA, DO, CT, DC, DE, FL, GA, HI, IA, ID, IL IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, HY, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, DS, TN, TX, UT, VA, VT, WA, WI, WV, W

Date initiated

2008-05-01

Date posted

2008-09-03

Date terminated

2011-12-11

Location

Minneapolis, MN