CLASS II ONGOING Device recall · Reported 5 Oct 2022 · FDA Enforcement Report
Medline Clearpro Trach Double Swivel Closed Suction recalled
MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Clearpro Trach Double Swivel Closed Suction Catheter, flat peel pouch EA, 10 EA, distributed nationwide in the US. The recall was initiated on 3 Aug 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1856-2022
- FDA event ID
- 90722
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Aug 2022
- FDA classified
- 29 Sep 2022
- Reported
- 5 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 3 Aug 2022 | Recall initiated by company | |
| 29 Sep 2022 | Classified by FDA | +57 days |
| 5 Oct 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled device when pulling the catheter out of the artificial airway in the patient suctioning process.
Product as listed by the FDA
MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. TRACH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12T b. TRACH DOUBLE SWIVEL, 14 Fr, Item Number/REF: DYNCPDS14T
Where it was distributed
Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico. International distribution to Canada, Chile, Colombia, Panama, Qatar, United Arab Emirates
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Is Medline Clearpro Trach Double Swivel Closed Suction Catheter, flat peel pouch EA, 10 EA recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline Clearpro Trach Double Swivel Closed Suction Catheter, flat peel pouch EA, 10 EA on 3 Aug 2022. The recall is Class II and its status is Ongoing. Recall number Z-1856-2022.
Why was it recalled?
Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled device when pulling the catheter out of the artificial airway in the patient suctioning process.
Which lots are affected?
a. UDI-DI (GTIN) case: (01)20888277703374; UDI-DI (GTIN) Each: (01)10888277703377, Lot Numbers 6921090011, 6922030011; b. UDI-DI (GTIN) case: (01)20888277703398; UDI-DI (GTIN) Each: (01)10888277703391, Lot Numbers 6921040012, 6921070011, 6921080011, 6921100011, 6921120011, 6921120021, 6922030011, 6922040011
Where was it sold?
Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico. International distribution to Canada, Chile, Colombia, Panama, Qatar, United Arab Emirates
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Heart & Vascular Devices recalls
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| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
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| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |