Contact Us

Arrow Sheath Introducers
*    Denotes required field.

   * First Name 

   * Last Name 

   * Email 

Phone 

Cell Phone 

Street Address 

Zip Code 

City 

State 

Date the device was implanted:

Is the device still implanted?

What medical condition prompted the use of the device?

Please describe any problems or injuries caused by the product:

For verification purposes, please answer the below question:
+
=

No Yes, I agree to the Parker Waichman LLP disclaimers. Click here to review.

Yes, I would like to receive the Parker Waichman LLP monthly newsletter, InjuryAlert.

please do not fill out the field below.


Arrow Sheath Introducers Recall

Jul 26, 1994 | www.fda.gov

PRODUCT:      
Arrow Percutaneous Sheath Introducer Kits with Polyurethane  Sheath:
               (a)  Product No. AKO9801S;
               (b)  Product No. AK09810S;
               (c)  Product No. AK09810C;
               (d)  Product No. BD09880;
               (e)  Product No. CK01000;
               (f)  Product No. DS09850S;
               (g)  Product No. IC09880;
               (h)  Product No. MH09800;
               (i)  Product No. H09810VKS;
               (j)  Product No. NR09810S;
               (k)  Product No. PS09810S;
               (l)  Product No. S109880SE;
               (m)  Product No. SJ09805;
               (n)  Product No. SV09804;
               (o)  Product No. UT09880;
               (p)  Product No. WB09810S;
               (q)  Product No. CK01410;
               (r)  Product No. AK09817S;
               (s)  Product No. CA09886;
               (t)  Product No. LJ09807S;
               (u)  Product No. PH09806.  
Recall #Z-051/071-5.

CODE    Lot numbers: 
(a)  AK91084, AK91404;
 (b)  AK91574, AK90944, AK91294;
 (c)  AK90524; (d) B0664, B0664A;
 (e)  C1574; (f) D0384; (g) I1124;
 (h)  H1004, MH09800;  (i) M1004;
(j)  NR0874, NR1294; (k) S1364; (l) I1224;
 (m)  S1784; (n) S2913; (o) T1014, T1014A;
(p)  W1924; (q) C1784Z; (r) AK90804;
 (s)  C0604; (t) L1574; (u) P1294.

MANUFACTURER:
Arrow International, Inc., Randleman, North Carolina.

RECALLED BY:
Arrow International, Inc., Reading, Pennsylvania, by  telephone beginning July 26, 1994, followed by letter July 28, 1994.  Firm-initiated recall ongoing.

DISTRIBUTION: Nationwide, Puerto Rico, Canada, Australia, Holland, Japan, United Kingdom.

QUANTITY: 20,905 units were distributed.

REASON:
A process change, file number REV-3958, was initiated to reduce the amount of scrap from shrinkage of the hub.  This process change was not validated.  Inadequate luer lock connections between the sheath and hemostasis valve can  result in bleeding or air embolisms to occur. 


Other articles
Parker Waichman Accolades And Reviews Best Lawyers Find Us On Avvo