Peachtree Corners, GA, United States
Stradis Medical, LLC dba Stradis Healthcare recalls
5 recalls recorded since 2018, most recently on 2 November 2022. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)4
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 November 2022
- Reason
- Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
- Distribution
- US nationwide distribution, and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0557-2023, Z-0544-2023, Z-0490-2023, Z-0530-2023, Z-0546-2023, Z-0505-2023, Z-0522-2023, Z-0542-2023, Z-0508-2023, Z-0512-2023, Z-0504-2023, Z-0517-2023 and 66 more
- HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,
- STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,
- STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray
- HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089
- STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,
- HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482
- HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891
- STRADIS HEALTHCARE, Surgery PK, Item No.682-1728,
- and 70 more product lines
Ongoing Class II Medical devices
- Recall started
- 25 July 2022
- Reason
- The sterile barrier may be compromised.
- Distribution
- US Nationwide distribution in the state of SC.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1553-2022, Z-1554-2022, Z-1552-2022
- NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
- NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701
- NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697
Ongoing Class II Medical devices
- Recall started
- 25 February 2022
- Reason
- The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
- Distribution
- US Nationwide distribution in the states of IN, TX, and PA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0866-2022, Z-0862-2022, Z-0865-2022, Z-0864-2022, Z-0863-2022
- Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
- Surgicare Neuro Pack - Neurological Kit
- Anterior Hip Pack - Surgical Kit
- Total Knee Pack - Surgical Kit
- Lum Lam Custom Pack - Anesthesia Kit
Terminated Class II Medical devices
- Recall started
- 28 October 2021
- Terminated
- 7 August 2023
- Reason
- This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set.
- Distribution
- NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0400-2022
- Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Ongoing Class II Medical devices
- Recall started
- 10 September 2021
- Reason
- Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
- Distribution
- Distributed nationwide to VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK, WA, NY, NV, MO, MD, IN, TX, CO, RI, NC, KY, MT, VI, GA, KS, MI, AK, ID, SD, UT and internationally to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0130-2022, Z-0127-2022, Z-0128-2022, Z-0126-2022, Z-0129-2022, Z-0131-2022
- Foundation Kit
- IUD Insertion Pack
- IUD Insertion Kit
- Tenaculum, Plastic
- Endometrial Biopsy Kit
- Standard IUD Insertion Kit
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.