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Terminated

SmartInfuser PainPump, Part numbers: P49220-S, P49230-S, P49230-SD, P49234-S, and P49234-SD.

FDA Recall Z-1982-2011 · Posted 2011-04-14

Recalling FirmHsmg, Inc. D/b/a Smartinfuser Usa
Recall StatusTerminated
Product CodeMEB
Date Initiated2010-03-17
Date Terminated2011-04-25
Product Quantity1,483 units

Reason for Recall

Elastomeric tube in product's compression unit has the potential to burst following filling.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061409SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SETPrecise Medical Products, Ltd. · 2006-06-16K042122SMARTINFUSER PAINPUMPPrecise Medical Products · 2004-09-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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