FDA Medical Device Recalls (openFDA)
Intersurgical Inc: Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
- Recall number
- Z-0753-2021
- Recalling firm
- Intersurgical Inc
- Product
- Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
- Status
- Terminated
- Initiated
- 2020-11-11
- Posted
- not on file
- Terminated
- 2022-08-09
- Reason
- The device was assembled with the incorrect exhalation port which can cause gas leakage.
- Root cause
- Process control
- Action
- Recall Strategy and Instruction: 1. Immediately discontinue use and quarantine any stock with the product/lot number described above in this recall notification. 2. If you have distributed any of these products, please immediately contact your customers, advise them of the recall situation and have them return their outstanding recalled stock to you. 3. Complete the Customer Product Recall Acknowledgement Form a. Return the completed form via email to Intersurgical Inc. at mhovey@intersurgicalinc.com. b. The subject line should contain Intersurgical Recall: Company name c. Please note: If you do not have the recalled product in stock, please check the appropriate box on the Customer Product Recall Acknowledgement Form. 4. Once we receive your Customer Product Recall Acknowledgement Form, Intersurgical Customer Support will issue a Return Goods Authorization (RGA) Number for the amount of product you have on-hand to return. a. Intersurgical will credit your account when the product is received. Intersurgical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact Customer Support at 800-828-9633 or email at support@intersurgicalinc.com. Distribution: Distribution began 09/02/2020 Distributed: 200 pieces
- Quantity
- 200 devices
- Distribution
- All of the devices were shipped to the same distributor (McKesson).
- Lot, serial or model codes
- Model Number: B0062001 Lot Numbers: 4200283 and 4200286 UDI Codes: (01)00081647202239(10)4200286 (01)00081647202239(10)4200283
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OFP
- Firm FEI
- 1000120301
- Firm city
- East Syracuse
- Firm state
- NY
- Firm country
- not on file
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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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