Theragenics Corporation: Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and

Is my product affected?

Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle.

• UPC 00813787021515

Check against the official notice below — it lists the full affected range.

What happened

Theragenics Corporation recalled Brachytherapy Applicator Needles (18g x 20cm) because some pouches containing the needles were not sealed. The recalled product consists of 480 packs, with each pack containing 5 needles. The affected needles were distributed nationwide to Florida, California, Alabama, Delaware, North Carolina, Texas, Utah, and Mississippi, as well as internationally to South Africa. The specific lot involved is identified by box part number CPPS-MN-1820, multipack part number CPPS-MN-1820-5, lot number 180904-80, and UDI (01)00813787021515(10)18090480(11)180904(17)220831.

The recall notice does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed

Details from the source

Reason for recall: Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed Distribution: Nationwide distribution to FL, CA, AL, DE, NC, TX, UT, MS. International distribution to South Africa. Quantity: 480 packs (5 needles each)  NOTE: The multipacks are part of a box of 25 needles, containing five (5) single packs and four (4) 5-packs. Lot/code info: Box part number CPPS-MN-1820; Multipack part number CPPS-MN-1820-5; UDI: (01)00813787021515(10)18090480(11)180904(17)220831; Lot # 180904-80

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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