Applied Medical Recalls Inzii Tissue Retrieval Bags Due to Packaging Punctures
Applied Medical is voluntarily recalling Inzii Tissue Retrieval Bags because packaging punctures could compromise the sterile barrier, posing a theoretical risk to patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 a voluntary precautionary measure for a theoretical risk (sterile barrier compromise) where the manufacturer states the likelihood of patient harm is highly unlikely, fitting the criteria for a moderate severity score.
Plain-English summary
Applied Medical Resources Corp is conducting a voluntary recall of the Inzii 12/15mm Retrieval System, specifically the Inzii Tissue Retrieval Bag, Model Number CD004. This Class II medical device is a disposable specimen retrieval bag intended for use as a receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. The recall involves 29,506 units distributed worldwide, including the United States and numerous international markets.
The recall is being initiated because the retrieval system packaging has the potential to become punctured with small holes during shipment. These punctures could compromise the sterile barrier of the device. Applied Medical states that the likelihood of this situation occurring and resulting in patient harm is highly unlikely, but the company is taking this action out of an abundance of caution for patient safety.
Healthcare providers and facilities that have received these devices should check their inventory for the specific lot numbers listed in the recall notice. If the affected units are found, they should be removed from service and returned to Applied Medical or their authorized distributor according to the company's instructions.
The recalled product
- Product
- Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as…
- Manufacturer
- Applied Medical Resources Corp
- Affected units
- 29,506
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 (20)
- Model Number CD004. Lot Nubmers: 1161268
- 1161269
- 1164934
- 1168358
- 1168361
- 1169317
- 1169318
- 1170694
- 1170700
- 1170701
- 1171214
- 1172482
- 1172664
- 1174287
- 1174793
- 1174857
- 1175123
- 1175280
- 1175472
- 1176555
Distribution
Distributed nationwide across the United States.
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