Food, drugs, devices › Stradis Healthcare
Device recall: Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
FDA enforcement event 91350 is a device recall by Stradis Healthcare of Waukegan, IL, initiated 15 Dec 2022 and classified Class II, with 18 product records.
FDA defines Class II as 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. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Stradis Healthcare has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Stradis Healthcare, Waukegan, IL.
Reason for recall
"Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit."
Distribution
"US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0931-2023 | Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile | 920 units | Class II | Ongoing | 18 Jan 2023 |
| Z-0932-2023 | PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc. | 300 units | Class II | Ongoing | 18 Jan 2023 |
| Z-0933-2023 | Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein. | 1,040 units | Class II | Ongoing | 18 Jan 2023 |
| Z-0934-2023 | Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pairs, 10 packs per case; c. Glove 7.5 Pack, 25 Pairs, 10 packs per case; d. Glove 8.0 Pack, 25 Pairs, 10 packs per case; e. Glove 8.5 Pack, 25 Pairs, 10 packs per case; f. Glove… | 21,755 units | Class II | Ongoing | 18 Jan 2023 |
| Z-0935-2023 | PICC KIT, 10/CS, ACCESS MEDICAL LABEL | 180 units | Class II | Ongoing | 18 Jan 2023 |
| Z-0936-2023 | HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology. | 644 units | Class II | Ongoing | 18 Jan 2023 |
| Z-0937-2023 | HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology. | 2,779 units | Class II | Ongoing | 18 Jan 2023 |
| Z-0938-2023 | HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology. | 112,675 units | Class II | Ongoing | 18 Jan 2023 |
| Z-0939-2023 | HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology. | 76,260 units | Class II | Ongoing | 18 Jan 2023 |
| Z-0940-2023 | HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology | 1,176 units | Class II | Ongoing | 18 Jan 2023 |
| Z-0941-2023 | HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology | 200 units | Class II | Ongoing | 18 Jan 2023 |
| Z-0942-2023 | Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group | 2,500 units | Class II | Ongoing | 18 Jan 2023 |
| Z-0943-2023 | McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution. | 250 units | Class II | Ongoing | 18 Jan 2023 |
| Z-0944-2023 | Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare. | 80 units | Class II | Ongoing | 18 Jan 2023 |
| Z-0945-2023 | Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc. | 1,175 units | Class II | Ongoing | 18 Jan 2023 |
| Z-0946-2023 | Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc. | 275 units | Class II | Ongoing | 18 Jan 2023 |
| Z-0947-2023 | Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc. | 600 units | Class II | Ongoing | 18 Jan 2023 |
| Z-0948-2023 | Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc. | 200 units | Class II | Ongoing | 18 Jan 2023 |
Context
Other enforcement events for Stradis Healthcare
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 10 May 2022 | VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS | Device | Class II | 1 |
| 22 Apr 2022 | Surgical Suture Kit | Device | Class II | 1 |
All 3 events for Stradis Healthcare
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.