ML20197C944
| ML20197C944 | |
| Person / Time | |
|---|---|
| Issue date: | 09/09/1998 |
| From: | Steven Baggett NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Robles G U.S. EMBASSIES |
| Shared Package | |
| ML20197C949 | List: |
| References | |
| SSD, NUDOCS 9809140319 | |
| Download: ML20197C944 (1) | |
Text
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$EP091998 P
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Guadalupe R.' Robles Commercial Assistant U.S. & Foreign Commercial Service 1
United States Embassy 1
Manila, Philippines 3
1
Dear Mr. Robles:
t This letter is in response to your August 17,199, letter to Carl Paperiello. Your letter i
questioned whether the U.S. Nuclear Regulatory Commission (NRC) regulates GammaMed l
catheter clamping adaptem and whether there has been a recall or withdrawal of GammaMed adapters. WRC does not regulate the catheters nor catheter clamping adapters. The U.S.
Food and Drug Administration regulates distribution of this type of equipment.
Even though NRC does not regulate the catheters nor catheter clamping adapters, NRC did issue information Notice 95-50, " Safety Defect in GammaMed 12i Bronchial Catheter Clamping Adapter." Specifically, NRC was concemed since, on more than one occasion, the adapter prohibited retrieval cf the source back to its shielded position. The Information Notice was sent to all users of high dose rate afterloaders to alert them to the manufacturer's recommendation to discontinue use of old style adapters. A copy of the Information Notice is enclosed.
i i-I Sincerely, WnalSigned$
StevenLBagget Steven L. Baggett, Deputy Branch Chief Materials Safety Branch i'
Division of Industrial and
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Medical Nuclear Safety Office of Nuclear Mcterial Safety
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and Safeguards i
Enclosure:
Distribution:
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