The Recall Desk
ModerateFDA (Devices)·Z-1191-2014·Announced 2014-03-19

Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes (Catalog Number G1777) due to an issue with the plunger tip. The product consists of sterile, single-use, in-vitro diagnostic devices used for drawing arterial blood via an arterial line. The syringes contain heparin and are not intended for injection.

The affected products were distributed worldwide, including in the United States and various international markets. The specific states and countries affected are listed in the distribution pattern provided by the agency.

Consumers and healthcare facilities should stop using the affected syringes and contact Smiths Medical ASD, Inc. for further instructions or a replacement.

The recalled product

Product
G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ devices and (2) Needle-Pro¿ Devices with 22G x 1¿needles Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 2491431

Distribution

Part of a larger recall action

This product is one of 13 recalled by Smiths Medical ASD, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

Same manufacturer · Smiths Medical ASD, Inc.

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