Applied Medical Dual Lumen Graft Cleaning Catheter Recall for Tip Separation
Applied Medical Resources Corp is recalling 28,799 Dual Lumen Graft Cleaning Catheters due to reports of tip separation during use, which may expose patients to unintended dislodgement.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 per the rubric, as Class I recalls involve a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Applied Medical Resources Corp is recalling 28,799 units of the Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic (REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE). The recall affects specific lot numbers: 1267676, 1272322, 1284680, 1295323, 1306127, 1312586, 1330450, 1334826, 1338738, and 1339555.
The firm initiated the recall after receiving reports of tip separation during usage. This defect may expose patients to the unintended dislodgement of the catheter tip from the body of the catheter.
The affected products were distributed worldwide, including nationwide in the United States and in Australia, Belgium, Canada, the Czech Republic, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, the Netherlands, Poland, Saudi Arabia, South Africa, Spain, Taiwan, and the United Kingdom. Healthcare facilities and distributors should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175
- Manufacturer
- Applied Medical Resources Corp
- Category
- Medical Device — Catheter
- Affected units
- 28,799
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 (13)
- Model A4GW6
- Applied Medical DUAL LUMEN GRAFT CLEANING CATETER
- 9mm X 60cm
- lot numbers 1267676
- 1272322
- 1284680
- 1295323
- 1306127
- 1312586
- 1330450
- 1334826
- 1338738
- 1339555
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Applied Medical Resources Corp 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.
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