Simplastic Suprapubic Puncture Instruments: Product Code Equivalent… — Class II medical device recall Z-1369-2018
Terminated recall by Teleflex Medical Europe Ltd, reported 2018-04-18, distributed nationwide. These products contain latex, but the following statement is not included on any level of product packaging: C
| Recall number | Z-1369-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical Europe Ltd, Athlone, Ireland |
| Recall initiated | 2018-03-15 |
| Classified | 2018-07-05 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2020-10-05 |
| Distributed | Nationwide (US) |
| Quantity | 4,220 units |
| Lot numbers | 13EE20, 13EG28, 13GE31, 13HE35, 13HG23, 13JE41, 13JE42, 13JE43, 13KE48, 14AE02, 14AE03, 14BE07, 14CE11, 14DE17, 14DE18, 14EE21, 14EG21, 14GE28, 14GE29, 14HE33, 14HE35, 14IE39, 14KE45, 15AE03, 15EE20, 15EE22, 15GE28, 15HE32, 15JE43, 15JE44 |
Product
Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120 551312 (c) 650704160 551316 Product Usage: RUSCH Simplastic Suprapubic Puncture Instruments are indicated for emergency suprapubic drainage of the bladder.
Reason for recall
These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1369-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.