Z-1369-2018Class II

Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120...

Name: Z-1369-2018 Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120...
Creator: Teleflex Medical Europe Ltd
Published: 2018-03-15
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2018-03-15 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical Europe Ltd began a recall of Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120 551312 (c) 650704160 551316 Product Usage: RUSCH... on 2018-03-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1369-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-15
Posted: 2018-04-12
Terminated: 2020-10-05
Recalling firm: Teleflex Medical
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.
Product code: GBM Catheter, Urethral
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm initiated their field correction on 03/15/2018 by letter. The notices stated the following: Affected distributors are instructed to take the following actions: 1. Place a copy of this notification with each unit of affected product currently in your inventory. 2. Using the provided customer letter template and acknowledgment form, communicate this notification to any of your customers who have received product included within the scope of this notification. 3. Have each of your customers who received the affected product return a completed acknowledgment form to you. 4. Once you have finished collecting and consolidating all of the acknowledgment forms, from your customers and placing a copy of this notification with each unit of affected product in your inventory, please complete the enclosed Distributor Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document completion of this recall. Affected direct customers are instructed to take the following actions: 1. Place a copy of this notification with each unit of affected product currently in your inventory. Users should note This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. 2. After step (1) is complete, fill out the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. Upon finding additional lots, the firm issued additional letter on 06/27/2018 with the same message as the letter disseminated in March.
Quantity in commerce: 4220 units
Distribution: US Nationwide Distribution
Product codes and lots: Product Code Equivalent Code (a) 650704100 551310 Batch Numbers: 13HE35 14KE45 (b) 650704120 551312 Batch Numbers: 13EE20 13HE35 13JE43 14AE02 14BE07 14EE21 14GE29 14IE39 15AE03 15HE32 (c) 650704160 551316 Batch Numbers: 13GE31 13HE35 13JE41 13JE42 13JE43 13KE48 14AE03 14BE07 14CE11 14DE17 14DE18 14EE21 14EG21 14GE28 14HE33 14HE35 14IE39 14KE45 15AE03 15EE20 15EE22 15GE28 15JE43 15JE44 13EG28 13HG23

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1369-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1367-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-07-05
Z-1368-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-07-05
Z-1369-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-07-05
Z-1370-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-07-05

Product code GBM

The FDA recall record names no cleared device, and no clearance has been matched to it.

Hollister recalls 2.5 million intermittent catheters over a manufacturing defect11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)