FDA Medical Device Recalls (openFDA)
RanD S.r.l.: Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
- Recall number
- Z-2048-2021
- Recalling firm
- RanD S.r.l.
- Product
- Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
- Status
- Terminated
- Initiated
- 2021-04-30
- Posted
- not on file
- Terminated
- 2024-02-05
- Reason
- The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.
- Root cause
- Material/Component Contamination
- Action
- An Urgent Medical Device Recall notification letter dated 4/30/21 was sent to customers. Reason for the Voluntary Recall: Our sterilization contractor informed us about a quality issue possibly affecting the sterilization process of a certain number of RAND products, thus leading us to open an immediate investigation. We have determined that the lots mentioned in the table below may be non-sterile. Risk to Health: The exposure to non-sterile products may result in an increased risk of patient infection. However we have not received any adverse event report regarding patient infection events associated with this field safety notice, so far. No specific follow up activities are required if the products have already been used. Actions to be taken by the Customer/User: Please proceed as follows: 1. Please check if you still have in your stock products belonging to the lot numbers below. Please refer to the reference code (REF) and the lot number (LOT) on the product label. 2. If you identify affected product, cease use immediately and put these products in quarantine. Please be sure that they are properly and clearly identified as on-hold to prevent their unintentional use. 3. Please fill in the form on the last page and return it to cristina.vaccari@rand-biotech.com as soon as possible, but no later than May 30, 2021. The form must be completed and returned even if you do not have affected product on hand. 4. If you identified non-conforming products in your inventory, you will receive further instructions on product disposition (return them to RAND or destroy them). Type of Action by the Company: No alternative products can be used, because only RanD sterile medical devices can be used in combination with the Performer HT equipment. RanD S.p.A. has already validated a different sterilization provider. New sterile products will be available in 1 - 2 month time. Contact details: If you have any questions or concerns regarding this notification, d
- Quantity
- 72
- Distribution
- The products were distributed to the following US states: FL, IL, TN, WI
- Lot, serial or model codes
- Lot Numbers: F180266 F180315 F190169
- 510(k) numbers
- ["K161613"]
- PMA numbers
- not on file
- Product code
- LGZ
- Firm FEI
- 3003793891
- Firm city
- Medolla
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28