ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/

FDA device recall Z-1869-2008 · posted 2008-09-11 · Terminated

Recall details

Recalling firm

I-Flow Corporation

Reason for recall

The ON-Q PainBuster, REF PS6504 (lot number 772166), box may contain the wrong product, ON-Q PainBuster, REF PS6502. If the wrong product is used, patients would receive a 2 ml/hr infusion rather than a 5 ml/hr infusion, which could result in inadequate pain relief.

Action taken

Firm sent letters on 2/12/2008 to affected customers advising of the possibility of an ON-Q PainBuster PS6502 (100 ml x 2 ml/hr) packed inside the ON-Q PainBuster PS6504 outer box. The intent of the letter is as follows: a) Inform customers of the potential for the wrong product inside the box. b) Require customers to inspect lot 772166 to ensure product inside is correct. c) If the product inside the box is correct, then no further action is required. d) If the product inside the box is incorrect, then the customer is advised to contact I-Flow Customer Service in order to exchange their product. Customers are also advised to send the letter to end users if they sold lot 772166 to other customers. Fax back forms will be provided to document customer compliance with the proposed field correction. If you have questions about this recall contact I-Flow Customer Service at 949-206-2700 from 8:00 am - 5:00 pm U.S. Pacific time.

Root cause

Other

Status

Terminated

Product code

MEB

Quantity affected

345 units shipped

Distribution

Internationally - United Kingdom, Germany, Spain, Denmark, Australia, and Italy

Date initiated

2008-02-12

Date posted

2008-09-11

Date terminated

2010-02-05

Location

Lake Forest, CA

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