Class 2 Device Recall SmartInfuser PainPump

• Date Initiated by Firm: March 17, 2010
• Date Posted: April 14, 2011
• Recall Status: Terminated on April 25, 2011
• Recall Number: Z-1982-2011
• Recall Event ID: 57776
• 510(K)Number: K042122 K061409
• Product Classification: Elastomeric Infusion Pump - Product Code MEB
• Product: SmartInfuser PainPump, Part numbers: P49220-S, P49230-S, P49230-SD, P49234-S, and P49234-SD.
• Code Information: Lot numbers: 1011004, 11011005, 1012004, 11012005, 11012006, 11012007, 11012008, 11042002, 11042003, 11014002, and 11044001.
• Recalling Firm/ Manufacturer: Hsmg, Inc. D/b/a Smartinfuser Usa; 8588 Katy Fwy Ste 348; Houston TX 77024-1822
• For Additional Information Contact: 281-413-5239
• Manufacturer Reason for Recall: Elastomeric tube in product's compression unit has the potential to burst following filling.
• FDA Determined Cause: Other
• Action: Firm notified consignees by e-mail and telephone on 3/17/2010. The correspondence identified the affected product and lot numbers; and asked that customers specify which parts, lot numbers and in what quantities they still had in their possession.
• Quantity in Commerce: 1,483 units
• Distribution: Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MEB and Original Applicant = PRECISE MEDICAL PRODUCTS; 510(K)s with Product Code = MEB and Original Applicant = PRECISE MEDICAL PRODUCTS, LTD.