FDA Medical Device Recalls (openFDA)
Repro-Med Systems, Inc.: Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.
- Recall number
- Z-0317-2018
- Recalling firm
- Repro-Med Systems, Inc.
- Product
- Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.
- Status
- Terminated
- Initiated
- 2016-03-10
- Posted
- 2018-01-05
- Terminated
- 2018-02-26
- Reason
- On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap in the supplier s manufacturing seal for Part number #317036 5 X 6.5 ST Bag Combo. the firm decided to recall Precision Flow Rate Tubing and RMS HIgH-Flo Subcutaneous Safety Needles Sets due to the sterile barrier packaging being found to have gaps during post-sterilization inspection of one lot of flow tubing, in which 701 out of 3,195 units were rejected for not passing inspection. The firm determined that the issue was large than just the one lot and recalled the product via March 10, 2016 Voluntary Medical Device Corrections and Removal Notification to customers. The recall was conducted without FDA notification.
- Root cause
- Nonconforming Material/Component
- Action
- On March 10, 2016 RMS Medical Products distributed Urgent Voluntary Medical Device Corrections and Removal notices to their customers. On March 12, 2016 & on March 18, 2016, RMS Medical Products distributed a 2nd Urgent Voluntary Medical Device Corrections and Removal notices to their customers advising them that affected products list was reduced after a comprehensive risk assessment was performed. Customers are advised to check stock, quarantine, cease distribution and remove product from use. If customers further distributed product, they are also encouraged to inform the affected parties. Customers are encouraged to complete and return the acknowledgement form via fax to: 845-469-5518.
- Quantity
- not on file
- Distribution
- Nationwide in US
- Lot, serial or model codes
- Lot Numbers: 1.053/16, 1.052/16, 1.051/16, 1.050/16, 1.049/16, 1.048/16, 1.047/16, 1.042/16, 1.041/16, 1.040/16, 1.039/16, 1.038/16, 1.037/16, 1.036/16, 1.033/16, & 1.030/16 Expiration: 2021-02
- 510(k) numbers
- ["K933652"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1318360
- Firm city
- Chester
- 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